Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-06-07 @ 12:20 AM
Study NCT ID:
NCT02654860
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2015-12-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C063450', 'term': '3-(cystein-S-yl)paracetamol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edonati@sintetica.com', 'phone': '+41.91.640.42.50', 'title': 'Dr.Elisabetta Donati, Corporate Director Scientific Affairs', 'organization': 'Sintetica SA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Clinical study duration (7 days)', 'eventGroups': [{'id': 'EG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'postprocedural constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'urinary retention postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'procedural vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'dyspespsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'epigastric disconfrort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'prupritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'antiementic supportive care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'Adverse event related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Adverse event not related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'In the first 24 hours, in the first 48 hours and at day 7±1', 'description': 'Phase 1: Number of participants with treatment evaluation and confirmation of the safety of the three doses of paracetamol 3% solution administered in the total number of patients enrolled', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 2: Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '11.9', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '24.5', 'spread': '19.5', 'groupId': 'OG002'}, {'value': '10.7', 'spread': '13.4', 'groupId': 'OG003'}]}]}, {'title': '1 hour after anaesthetic', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': '6 hours after anaesthetic', 'categories': [{'measurements': [{'value': '21.5', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '25', 'groupId': 'OG001'}, {'value': '20.3', 'spread': '25.3', 'groupId': 'OG002'}, {'value': '42.3', 'spread': '31.5', 'groupId': 'OG003'}]}]}, {'title': '9 hours after anaesthetic', 'categories': [{'measurements': [{'value': '21.6', 'spread': '18', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '24', 'groupId': 'OG002'}, {'value': '26.3', 'spread': '22.3', 'groupId': 'OG003'}]}]}, {'title': '12 hours after anaesthetic', 'categories': [{'measurements': [{'value': '13.1', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '17.5', 'groupId': 'OG002'}, {'value': '17.9', 'spread': '16.7', 'groupId': 'OG003'}]}]}, {'title': '15 hours after anaesthetic', 'categories': [{'measurements': [{'value': '15.4', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '13.8', 'groupId': 'OG002'}, {'value': '20.5', 'spread': '21.5', 'groupId': 'OG003'}]}]}, {'title': '24 hours after anaesthetic', 'categories': [{'measurements': [{'value': '11.4', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '14.9', 'groupId': 'OG002'}, {'value': '16', 'spread': '18.3', 'groupId': 'OG003'}]}]}, {'title': '48 hours after anaesthetic', 'categories': [{'measurements': [{'value': '6.1', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '12.9', 'groupId': 'OG002'}, {'value': '8.7', 'spread': '11.6', 'groupId': 'OG003'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '8.0', 'spread': '9.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (0 h), 1, 6, 9, 12, 15, 24, and 48 h after anaesthetic IT injection and at discharge', 'description': 'Phase 2: Pain intensity at rest evaluated as VAS scores ( 0-100 mm visual analogue scale : 0 is the absence pain and 100 is the maximum pain sensation)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'first 24 hours', 'categories': [{'measurements': [{'value': '14.1', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '14.7', 'groupId': 'OG002'}, {'value': '14.3', 'spread': '7.4', 'groupId': 'OG003'}]}]}, {'title': 'first 48 hours', 'categories': [{'measurements': [{'value': '24.5', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '33.5', 'spread': '21.5', 'groupId': 'OG002'}, {'value': '21', 'spread': '12.8', 'groupId': 'OG003'}]}]}, {'title': 'entire study period', 'categories': [{'measurements': [{'value': '24.8', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '33.8', 'spread': '21.4', 'groupId': 'OG002'}, {'value': '21.1', 'spread': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 24 and 48 h after anaesthetic IT injection and entire study period, up to 7 days', 'description': 'Phase 2: Total morphine use', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to First Morphine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000', 'lowerLimit': '275', 'upperLimit': '503'}, {'value': '236', 'groupId': 'OG001', 'lowerLimit': '181', 'upperLimit': '322'}, {'value': '318', 'groupId': 'OG002', 'lowerLimit': '184', 'upperLimit': '415'}, {'value': '279', 'groupId': 'OG003', 'lowerLimit': '169', 'upperLimit': '313'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative, up to 48 hours after end of surgery', 'description': 'Phase 2: Time to first morphine use (minutes)', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With Need for Supplemental Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative, up to 48 hours after end of surgery', 'description': 'Phase 2: Need for supplementary analgesia, other than the planned morphine PCA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Morphine-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 24 hours after surgery, up to 48 hours', 'description': 'Percentage of subjects experiencing during the study the morphine-related adverse events pre-specified in the protocol', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Readiness for Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '11'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative', 'description': 'Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2:Maximum Level of Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'T1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'T5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T6', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'T7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'T8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'T9', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'T10', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T11', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Intraoperative', 'description': 'Sensorial block will be verified by bilateral Pinprick test using a 20-G hypodermic needle and will be recorded. Pinprick sensation will be scored as being present (score 1) or absent (score 0). Onset of sensory block is defined as an absent touch sensation (score 0)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '20'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '13', 'upperLimit': '20'}, {'value': '17', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative', 'description': 'Time to maximum level of sensory block', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Regression of Spinal Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '285', 'groupId': 'OG000', 'lowerLimit': '260', 'upperLimit': '345'}, {'value': '246', 'groupId': 'OG001', 'lowerLimit': '228', 'upperLimit': '280'}, {'value': '265', 'groupId': 'OG002', 'lowerLimit': '245', 'upperLimit': '303'}, {'value': '280', 'groupId': 'OG003', 'lowerLimit': '232', 'upperLimit': '302'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from readiness for surgery,then every 10 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 30 min until regression of spinal block', 'description': 'Time period from spinal injection (time 0 h) to the time when the Bromage score returns to 0 and sensitive perception returns to S1. Bromage scale:\n\nI - Free movement of legs and feet II - Just able to flex knees with free movement of feet III - Unable to flex knees, but with free movement of feet IV - Unable to move legs or feet', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'systolic Blood Pressure at screening', 'categories': [{'measurements': [{'value': '137', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '144.6', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '148.5', 'spread': '14.7', 'groupId': 'OG002'}, {'value': '147.7', 'spread': '15.7', 'groupId': 'OG003'}]}]}, {'title': 'systolic Blood Pressure at baseline', 'categories': [{'measurements': [{'value': '145.5', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '146.3', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '138.7', 'spread': '10.5', 'groupId': 'OG002'}, {'value': '144.8', 'spread': '12.3', 'groupId': 'OG003'}]}]}, {'title': 'systolic Blood Pressure at end of the study (day6)', 'categories': [{'measurements': [{'value': '130', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '130.3', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '133.5', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '138.1', 'spread': '14.5', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure at screening', 'categories': [{'measurements': [{'value': '87.1', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '85.7', 'spread': '7', 'groupId': 'OG001'}, {'value': '90.9', 'spread': '8.2', 'groupId': 'OG002'}, {'value': '87', 'spread': '5.1', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure at baseline', 'categories': [{'measurements': [{'value': '83', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '77.8', 'spread': '10', 'groupId': 'OG002'}, {'value': '85.9', 'spread': '5.8', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure at end of the study (day6)', 'categories': [{'measurements': [{'value': '79.5', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '78.2', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '79', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '83.1', 'spread': '9.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at screening, at baseline (before the spinal injection) and at end of the study (Day 6).', 'description': 'Systolic and Diastolic Blood Pressure (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase2: Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'heparin group', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Second-generation cephalosporins', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Solutions affecting the electrolyte balance', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Direct factor Xa inhibi', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Amino acids', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'propofol', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Adrenergic and dopaminergic agents', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Propionic acid derivatives', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Pyrazolones', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Acetic acid derivatives and related substances', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Osmotically acting laxatives', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Proton pump inhibitors', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Serotonin (5HT3) antagonists', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Benzodiazepine derivatives', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'ANTIEMETICS AND ANTINAUSEANTS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Other opioids', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Platelet aggregation inhibitors excl. heparin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Angiotensin II antagonists,', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Natural opium alkaloids', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at screening, at baseline until the end of the study (Day 6)', 'description': 'record the concomitant medications intaked during the study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: SpO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'screening', 'categories': [{'measurements': [{'value': '97.93', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '98', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '98.27', 'spread': '0.70', 'groupId': 'OG002'}, {'value': '97.80', 'spread': '0.77', 'groupId': 'OG003'}]}]}, {'title': 'baseline', 'categories': [{'measurements': [{'value': '97.27', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '97.07', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '97.33', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '96.87', 'spread': '1.36', 'groupId': 'OG003'}]}]}, {'title': 'end of the study (day 6)', 'categories': [{'measurements': [{'value': '97.73', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '97.53', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '97.8', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '97.6', 'spread': '0.74', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at screening, at baseline (before the spinal injection) and at the end of the study (day 6)', 'description': 'Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood.', 'unitOfMeasure': 'Oxygen Saturation percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'OG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'classes': [{'title': 'screening', 'categories': [{'title': 'normal', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Abnormal, Not Clinically Significant', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Abnormal, Clinically Significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'baseline', 'categories': [{'title': 'normal', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': 'Abnormal, Not Clinically Significant', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Abnormal, Clinically Significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'end of study', 'categories': [{'title': 'normal', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': 'Abnormal, Not Clinically Significant', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Abnormal, Clinically Significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'screening, baseline and end of study (Day 6±1)', 'description': 'Electrocardiography is the process of producing an electrocardiogram (ECG), it is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'FG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'FG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'FG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}], 'periods': [{'title': 'First Part', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Part', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'BG001', 'title': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'BG002', 'title': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.\n\nParacetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'BG003', 'title': 'Phase II Only: Saline Solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nPlacebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.\n\nStudy part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.\n\nHyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '65.1', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '65.1', 'spread': '7.7', 'groupId': 'BG003'}, {'value': '64.8', 'spread': '7.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-01', 'size': 1793218, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-04T09:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Phase II only'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4 arms for Phase II only'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2015-12-23', 'resultsFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-05', 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol', 'timeFrame': 'In the first 24 hours, in the first 48 hours and at day 7±1', 'description': 'Phase 1: Number of participants with treatment evaluation and confirmation of the safety of the three doses of paracetamol 3% solution administered in the total number of patients enrolled'}, {'measure': 'Phase 2: Pain Intensity', 'timeFrame': 'baseline (0 h), 1, 6, 9, 12, 15, 24, and 48 h after anaesthetic IT injection and at discharge', 'description': 'Phase 2: Pain intensity at rest evaluated as VAS scores ( 0-100 mm visual analogue scale : 0 is the absence pain and 100 is the maximum pain sensation)'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Morphine', 'timeFrame': 'At 24 and 48 h after anaesthetic IT injection and entire study period, up to 7 days', 'description': 'Phase 2: Total morphine use'}, {'measure': 'Phase 2: Time to First Morphine Use', 'timeFrame': 'Postoperative, up to 48 hours after end of surgery', 'description': 'Phase 2: Time to first morphine use (minutes)'}, {'measure': 'Phase 2: Number of Participants With Need for Supplemental Analgesia', 'timeFrame': 'Postoperative, up to 48 hours after end of surgery', 'description': 'Phase 2: Need for supplementary analgesia, other than the planned morphine PCA'}, {'measure': 'Phase 2: Morphine-related Adverse Events', 'timeFrame': 'up to 24 hours after surgery, up to 48 hours', 'description': 'Percentage of subjects experiencing during the study the morphine-related adverse events pre-specified in the protocol'}, {'measure': 'Phase 2: Time to Readiness for Surgery', 'timeFrame': 'Intraoperative', 'description': 'Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery.'}, {'measure': 'Phase 2:Maximum Level of Sensory Block', 'timeFrame': 'Intraoperative', 'description': 'Sensorial block will be verified by bilateral Pinprick test using a 20-G hypodermic needle and will be recorded. Pinprick sensation will be scored as being present (score 1) or absent (score 0). Onset of sensory block is defined as an absent touch sensation (score 0)'}, {'measure': 'Phase 2: Time to Sensory Block', 'timeFrame': 'Intraoperative', 'description': 'Time to maximum level of sensory block'}, {'measure': 'Phase 2: Time to Regression of Spinal Block', 'timeFrame': 'from readiness for surgery,then every 10 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 30 min until regression of spinal block', 'description': 'Time period from spinal injection (time 0 h) to the time when the Bromage score returns to 0 and sensitive perception returns to S1. Bromage scale:\n\nI - Free movement of legs and feet II - Just able to flex knees with free movement of feet III - Unable to flex knees, but with free movement of feet IV - Unable to move legs or feet'}, {'measure': 'Phase 2: Vital Signs', 'timeFrame': 'at screening, at baseline (before the spinal injection) and at end of the study (Day 6).', 'description': 'Systolic and Diastolic Blood Pressure (mmHg)'}, {'measure': 'Phase2: Concomitant Medications', 'timeFrame': 'at screening, at baseline until the end of the study (Day 6)', 'description': 'record the concomitant medications intaked during the study'}, {'measure': 'Phase 2: SpO2', 'timeFrame': 'at screening, at baseline (before the spinal injection) and at the end of the study (day 6)', 'description': 'Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood.'}, {'measure': 'Phase 2: ECG', 'timeFrame': 'screening, baseline and end of study (Day 6±1)', 'description': 'Electrocardiography is the process of producing an electrocardiogram (ECG), it is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Phase 1: Pain Management', 'Phase 2: Pain Management']}, 'descriptionModule': {'briefSummary': 'Two-part study of intrathecal paracetamol administered immediately before spinal anaesthesia in patients scheduled for hip replacement surgery', 'detailedDescription': 'This is a prospective, single centre, two-part, three doses study. Part 1 is a Phase I, three cohorts, dose-ascending, open-label, safety study. Part 2 is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, exploratory efficacy and safety study The objective of the study is to investigate the efficacy and safety of a single intrathecal injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared to placebo solution, for post-operative analgesia of hip replacement surgery performed under spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4 treatment groups (15 patients per group) to receive either one of the 3 single doses of paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution) by intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration, all patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤ 160 cm-tall patients and 15 mg for \\> 160 cm-tall patients). The time interval between paracetamol IT and bupivacaine IT administrations should not exceed 2 min.\n\nThe study will include a screening phase (Visit 1, Days -21/1), a treatment phase (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase including an observation period (Visit 3, from Day 1 after surgery until discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a 0-100 mm VAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria Phase 1 and Phase 2:\n\n* Informed consent: signed written informed consent before inclusion in the study\n* Sex, age and surgery: male/female 18-80 years (inclusive) old patients, scheduled for hip replacement surgery, with anticipated need for post-operative narcotic analgesia, adequate i.v. access and anticipated hospital stay \\> 48 hours.\n* Body Mass Index (BMI): 18 - 34 kg/m2 inclusive\n* ASA physical status: I-III\n* Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study\n* Inclusion criteria - Phase 1 only : Age: 18-70 (inclusive) old patients\n* Inclusion criteria - Phase 2 only : Age: 18-80 (inclusive) old patients Hospital stay: Patients with anticipated hospital stay \\> 48 hours\n\nExclusion Criteria Phase 1 and Phase 2:\n\n* Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities\n* ASA physical status: IV-V\n* Further anaesthesia: patients expected to require further anaesthesia\n* Pain assessment: anticipated to be unable to make a reliable self-report of pain intensity\n* Allergy: ascertained or presumptive hypersensitivity to the active principles (paracetamol and/or amide type anaesthetics) and/or formulations' ingredients or related drugs, opioids, non-steroidal anti-inflammatory drugs; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers could affect the outcome of the study\n* Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes, other neuropathies, history or evidence of asthma or heart failure. History of severe head trauma that required hospitalisation, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.\n* Liver function: Impaired liver function (transaminases \\> twice upper limit)\n* Renal function: Renal dysfunction (creatinine \\> 2.0 mg/dL)\n* Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study\n* Drug, alcohol: history of drug or alcohol abuse. Pre-existing dependence on narcotics or known tolerance to opioids\n* Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating women \\[The pregnancy test will be performed to all fertile women and to all women up to 55 years old, if not in proven menopause (available laboratory test confirming menopause or surgically sterilised)\\]\n* Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, anticonvulsant agents or chronic analgesic therapy).\n* Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Paracetamol formulations, other than the investigational product, for 1 week before the start of the study and during the study. Hormonal contraceptives for females are allowed.\n* Phase 2 only - Exclusion criteria Pain assessment: anticipated to be unable to make a reliable self-report of pain intensity"}, 'identificationModule': {'nctId': 'NCT02654860', 'briefTitle': 'Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sintetica SA'}, 'officialTitle': 'Two-part Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia in Patients Scheduled for Hip Replacement Surgery', 'orgStudyIdInfo': {'id': 'PAR.3/02-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '60 mg Paracetamol 3% (2 mL)', 'description': '60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.', 'interventionNames': ['Drug: Paracetamol 3%', 'Drug: Hyperbaric Bupivacaine HCl 0.5%']}, {'type': 'EXPERIMENTAL', 'label': '90 mg Paracetamol 3% (3 mL)', 'description': '90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.', 'interventionNames': ['Drug: Paracetamol 3%', 'Drug: Hyperbaric Bupivacaine HCl 0.5%']}, {'type': 'EXPERIMENTAL', 'label': '120 mg Paracetamol 3% (4mL)', 'description': '120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.', 'interventionNames': ['Drug: Paracetamol 3%', 'Drug: Hyperbaric Bupivacaine HCl 0.5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase II Only: Saline solution 0.9%', 'description': 'Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.', 'interventionNames': ['Drug: Placebo injection containing Saline solution 0.9%', 'Drug: Hyperbaric Bupivacaine HCl 0.5%']}], 'interventions': [{'name': 'Paracetamol 3%', 'type': 'DRUG', 'description': 'Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery', 'armGroupLabels': ['120 mg Paracetamol 3% (4mL)', '60 mg Paracetamol 3% (2 mL)', '90 mg Paracetamol 3% (3 mL)']}, {'name': 'Placebo injection containing Saline solution 0.9%', 'type': 'DRUG', 'description': 'Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.', 'armGroupLabels': ['Phase II Only: Saline solution 0.9%']}, {'name': 'Hyperbaric Bupivacaine HCl 0.5%', 'type': 'DRUG', 'description': 'NIMP, spinal anaesthetic before the surgical procedure', 'armGroupLabels': ['120 mg Paracetamol 3% (4mL)', '60 mg Paracetamol 3% (2 mL)', '90 mg Paracetamol 3% (3 mL)', 'Phase II Only: Saline solution 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-6929', 'city': 'Gravesano', 'state': 'Lugano', 'country': 'Switzerland', 'facility': 'Claudio Camponovo', 'geoPoint': {'lat': 46.04208, 'lon': 8.91832}}], 'overallOfficials': [{'name': 'Claudio Camponovo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sintetica SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cross S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}