Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-03-05 @ 4:33 AM
Study NCT ID:
NCT02481505
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2015-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edonati@sintetica.com', 'phone': '+41.91.640.42.50', 'title': 'Elisabetta Donati Clinical Project Leader', 'organization': 'Sintetica SA, via Penate 5 Mendrisio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 days', 'description': 'No SAEs and No subject discontinued for AEs', 'eventGroups': [{'id': 'EG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Procedural pain', 'notes': 'The most frequent AE was procedural pain (verbatim: pain at the site of surgery)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhoae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Regression of Spinal Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '41.5', 'spread': '13.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 hours after regression of two dermatomers', 'description': 'When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '3', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 40 min after spinal injection', 'description': 'Time period from spinal injection (time 0 h) to achievement of sensory block The evolution of both sensory and motor blocks, including sensory block metameric level, will be evaluated every 2 min until readiness for surgery, every 5 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 5 min until regression of two dermatomers with respect to the maximum level of sensory block.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Motor Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '6', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 40 min after spinal injection', 'description': 'Time period from spinal injection (time 0 h) to achievement of motor block', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Readiness for Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 40 min after spinal injection', 'description': "Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery, i.e. loss of Pinprick sensation and Bromage's score ≥ 2 at the required metameric level ≥ T12", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Regression of Spinal Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '1.761', 'spread': '0.348', 'groupId': 'OG000'}, {'value': '2.127', 'spread': '0.457', 'groupId': 'OG001'}, {'value': '2.229', 'spread': '0.379', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 h and 40 min after readiness for surgery', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Sensory Block to S1(Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '1.761', 'spread': '0.348', 'groupId': 'OG000'}, {'value': '2.127', 'spread': '0.457', 'groupId': 'OG001'}, {'value': '2.195', 'spread': '0.386', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Motor Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '2.662', 'spread': '0.789', 'groupId': 'OG000'}, {'value': '3.361', 'spread': '1.120', 'groupId': 'OG001'}, {'value': '3.213', 'spread': '0.856', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when the Bromage score has returned to 0 (Bromage Scale comprises from 1 to 4, where 1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Unassisted Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '2.662', 'spread': '0.789', 'groupId': 'OG000'}, {'value': '3.361', 'spread': '1.120', 'groupId': 'OG001'}, {'value': '3.213', 'spread': '0.856', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sensory Block Metameric Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'T2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'T6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'T7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'T8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'T10', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'T12', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'L1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Level of Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'T2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'T6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'T7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'T8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'T10', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'T12', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'L1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 h and 40 min after readiness for surgery', 'description': 'Maximum metameric level of sensory block (decreased or absent sensation) achieved', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Level of Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '0.224', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.235', 'spread': '0.077', 'groupId': 'OG001'}, {'value': '0.234', 'spread': '0.098', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 h and 40 min after readiness for surgery', 'description': 'Time period from spinal injection (Tsp; time 0 h) to the time when the maximum metameric level of sensory block is achieved (consider the time of the first of the two consecutive observations with the same level of sensory block)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '0.687', 'spread': '0.361', 'groupId': 'OG000'}, {'value': '0.851', 'spread': '0.468', 'groupId': 'OG001'}, {'value': '0.695', 'spread': '0.290', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when the sensory block decrease of two dermatomers with respect to the maximum level of sensory block', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Eligibility for Home Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '3.021', 'spread': '1.012', 'groupId': 'OG000'}, {'value': '3.545', 'spread': '1.281', 'groupId': 'OG001'}, {'value': '3.530', 'spread': '0.887', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'Time period from spinal injection (time 0 h) to the time when the criteria from discharge are met, even if according to the hospital procedures the patient is discharged at a later time', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Spontaneous Urine Voiding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '2.530', 'spread': '0.761', 'groupId': 'OG000'}, {'value': '3.361', 'spread': '1.120', 'groupId': 'OG001'}, {'value': '3.067', 'spread': '0.755', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Post-operative Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '8.186', 'spread': '10.815', 'groupId': 'OG000'}, {'value': '2.928', 'spread': '1.228', 'groupId': 'OG001'}, {'value': '2.988', 'spread': '1.167', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'Time from spinal injection (time 0 h) to first post-operative analgesia', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Administration of Rescue Anaesthesia or Rescue Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '0.717', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '0.315', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Expected up to 24 hrs post surgery', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': '5 minutes post-dose', 'categories': [{'measurements': [{'value': '16.127', 'spread': '20.108', 'groupId': 'OG000'}, {'value': '20.411', 'spread': '23.037', 'groupId': 'OG001'}, {'value': '24.887', 'spread': '20.340', 'groupId': 'OG002'}]}]}, {'title': '10 minutes post-dose', 'categories': [{'measurements': [{'value': '41.440', 'spread': '31.778', 'groupId': 'OG000'}, {'value': '38.851', 'spread': '25.492', 'groupId': 'OG001'}, {'value': '75.833', 'spread': '67.635', 'groupId': 'OG002'}]}]}, {'title': '30 minutes post-dose', 'categories': [{'measurements': [{'value': '57.459', 'spread': '43.773', 'groupId': 'OG000'}, {'value': '67.180', 'spread': '36.899', 'groupId': 'OG001'}, {'value': '97.647', 'spread': '61.704', 'groupId': 'OG002'}]}]}, {'title': '60 minutes post-dose', 'categories': [{'measurements': [{'value': '47.020', 'spread': '41.381', 'groupId': 'OG000'}, {'value': '53.093', 'spread': '31.803', 'groupId': 'OG001'}, {'value': '78.380', 'spread': '48.403', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at pre-dose, 5, 10, 30 and 60 min after spinal puncture', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'categories': [{'measurements': [{'value': '1217.7', 'spread': '627.8', 'groupId': 'OG000'}, {'value': '1827.9', 'spread': '904.1', 'groupId': 'OG001'}, {'value': '2103.5', 'spread': '1537.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at the time of first urine voiding post surgery', 'description': 'Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'Procedural pain', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 6 +/- 1 after spinal puncture', 'description': 'All AEs occurring or worsening after the dose of IMP', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transient Neurological Symptoms (TNS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 6 +/- 1 after spinal puncture', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Assessment at the Site of Injection and at the Site of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'Immediately after regression of spinal block', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'discharge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'day 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'day 7', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 6 +/- 1 after spinal puncture', 'description': 'Number of patients with pain at the site of injection and at the site of surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'screening', 'categories': [{'measurements': [{'value': '62.2', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '67.5', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '70.7', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': 'baseline', 'categories': [{'measurements': [{'value': '63.1', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '71', 'spread': '14', 'groupId': 'OG001'}, {'value': '71.7', 'spread': '9.2', 'groupId': 'OG002'}]}]}, {'title': 'discharge', 'categories': [{'measurements': [{'value': '64.9', 'spread': '7', 'groupId': 'OG000'}, {'value': '66.9', 'spread': '10', 'groupId': 'OG001'}, {'value': '67', 'spread': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'The following normal ranges Heart Rate parameters will be used:\n\n50-90 beats/min', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'Systolic Blood Pressure screening', 'categories': [{'measurements': [{'value': '120', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '126', 'spread': '21.74', 'groupId': 'OG001'}, {'value': '121.6', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure baseline', 'categories': [{'measurements': [{'value': '116.9', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '127.9', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '125.5', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure discharge', 'categories': [{'measurements': [{'value': '116.9', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '124.7', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '121.7', 'spread': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure screening', 'categories': [{'measurements': [{'value': '81.5', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '80.5', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure baseline', 'categories': [{'measurements': [{'value': '74.5', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '79.8', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '79.1', 'spread': '13.3', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure discharge', 'categories': [{'measurements': [{'value': '75.5', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '79', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '82', 'spread': '9.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used:\n\nSystolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SpO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'OG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'classes': [{'title': 'screening', 'categories': [{'measurements': [{'value': '99.7', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '99.13', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '98.53', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': 'baseline', 'categories': [{'measurements': [{'value': '99.4', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '99.13', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '98.53', 'spread': '1.51', 'groupId': 'OG002'}]}]}, {'title': 'discharge', 'categories': [{'measurements': [{'value': '99.33', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '99.33', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '99', 'spread': '1.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'The following normal ranges SpO2 parameters will be used:\n\nPeripheral Oxygen Saturation: ≥ 95%', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'FG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'FG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'BG001', 'title': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'BG002', 'title': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)\n\nChloroprocaine HCl 1%: Intrathecal Route'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0.0', 'groupId': 'BG000'}, {'value': '0.0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '41.5', 'spread': '13.9', 'groupId': 'BG002'}, {'value': '40.6', 'spread': '12.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-03', 'size': 949631, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-26T08:44', 'hasProtocol': True}, {'date': '2016-02-02', 'size': 10853445, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-26T08:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2015-06-02', 'resultsFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-26', 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Regression of Spinal Block', 'timeFrame': 'Up to 5 hours after regression of two dermatomers', 'description': 'When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)'}], 'secondaryOutcomes': [{'measure': 'Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)', 'timeFrame': 'Up to 40 min after spinal injection', 'description': 'Time period from spinal injection (time 0 h) to achievement of sensory block The evolution of both sensory and motor blocks, including sensory block metameric level, will be evaluated every 2 min until readiness for surgery, every 5 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 5 min until regression of two dermatomers with respect to the maximum level of sensory block.'}, {'measure': 'Time to Onset of Motor Block', 'timeFrame': 'Up to 40 min after spinal injection', 'description': 'Time period from spinal injection (time 0 h) to achievement of motor block'}, {'measure': 'Time to Readiness for Surgery', 'timeFrame': 'Up to 40 min after spinal injection', 'description': "Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery, i.e. loss of Pinprick sensation and Bromage's score ≥ 2 at the required metameric level ≥ T12"}, {'measure': 'Time to Regression of Spinal Block', 'timeFrame': 'Up to 1 h and 40 min after readiness for surgery'}, {'measure': 'Time to Resolution of Sensory Block to S1(Min)', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1'}, {'measure': 'Time to Resolution of Motor Block', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when the Bromage score has returned to 0 (Bromage Scale comprises from 1 to 4, where 1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)'}, {'measure': 'Time to Unassisted Ambulation', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted'}, {'measure': 'Sensory Block Metameric Level', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1'}, {'measure': 'Maximum Level of Sensory Block', 'timeFrame': 'Up to 1 h and 40 min after readiness for surgery', 'description': 'Maximum metameric level of sensory block (decreased or absent sensation) achieved'}, {'measure': 'Time to Maximum Level of Sensory Block', 'timeFrame': 'Up to 1 h and 40 min after readiness for surgery', 'description': 'Time period from spinal injection (Tsp; time 0 h) to the time when the maximum metameric level of sensory block is achieved (consider the time of the first of the two consecutive observations with the same level of sensory block)'}, {'measure': 'Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block', 'timeFrame': 'Up to 5 h after regression of two dermatomers', 'description': 'Time period from spinal injection (time 0 h) to the time when the sensory block decrease of two dermatomers with respect to the maximum level of sensory block'}, {'measure': 'Time to Eligibility for Home Discharge', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'Time period from spinal injection (time 0 h) to the time when the criteria from discharge are met, even if according to the hospital procedures the patient is discharged at a later time'}, {'measure': 'Time to First Spontaneous Urine Voiding', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted'}, {'measure': 'Time to First Post-operative Analgesia', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'Time from spinal injection (time 0 h) to first post-operative analgesia'}, {'measure': 'Time to Administration of Rescue Anaesthesia or Rescue Analgesia', 'timeFrame': 'Expected up to 24 hrs post surgery'}, {'measure': 'Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma', 'timeFrame': 'at pre-dose, 5, 10, 30 and 60 min after spinal puncture'}, {'measure': 'Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine', 'timeFrame': 'at the time of first urine voiding post surgery', 'description': 'Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted'}, {'measure': 'Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 6 +/- 1 after spinal puncture', 'description': 'All AEs occurring or worsening after the dose of IMP'}, {'measure': 'Transient Neurological Symptoms (TNS)', 'timeFrame': 'Up to Day 6 +/- 1 after spinal puncture'}, {'measure': 'Pain Assessment at the Site of Injection and at the Site of Surgery', 'timeFrame': 'Up to Day 6 +/- 1 after spinal puncture', 'description': 'Number of patients with pain at the site of injection and at the site of surgery'}, {'measure': 'Heart Rate', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'The following normal ranges Heart Rate parameters will be used:\n\n50-90 beats/min'}, {'measure': 'Blood Pressure', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used:\n\nSystolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg'}, {'measure': 'SpO2', 'timeFrame': 'Expected up to 24 hrs post surgery', 'description': 'The following normal ranges SpO2 parameters will be used:\n\nPeripheral Oxygen Saturation: ≥ 95%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Short Duration Lower Limb Surgery Via Spinal Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '33610175', 'type': 'DERIVED', 'citation': 'Ghisi D, Boschetto G, Spinelli AM, Giannone S, Frugiuele J, Ciccarello M, Bonarelli S. Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients. BMC Anesthesiol. 2021 Feb 20;21(1):58. doi: 10.1186/s12871-021-01279-9.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Patients undergoing elective short-duration lower limb surgery will be randomised into 3 treatment groups (15 patients per group) to receive one of the 3 single doses of Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.', 'detailedDescription': 'To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (i.e. D1, D2 and D3) in terms of time to complete regression of spinal block (i.e. end of anaesthesia)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sex, age and surgery: male/female patients, 18-65 years old, scheduled for short duration (less than 40 min) lower limb surgery requiring ≥ T12 metameric level of sensory block\n2. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive\n3. ASA physical status: I-II\n4. Informed consent: signed written informed consent before inclusion in the study 5. 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\nExclusion Criteria:\n\n1. 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\n2. ASA physical status: III-V\n3. Further anaesthesia: patients expected to require further anaesthesia\n4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics\n5. 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 or other neuropathies.\n6. 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\n7. Drug, alcohol: history of drug or alcohol abuse\n8. Blood donation: blood donations in the 3 months before this study\n9. Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women\n10. Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents or chronic analgesic therapy) 11. Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Hormonal contraceptives for females are allowed.'}, 'identificationModule': {'nctId': 'NCT02481505', 'briefTitle': 'Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sintetica SA'}, 'officialTitle': 'Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration: a Prospective, Randomised, Observer-blind Study in Adult Patients', 'orgStudyIdInfo': {'id': 'CHL.1/02-2014'}, 'secondaryIdInfos': [{'id': '2014-003778-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 mL Chloroprocaine HCl 1%', 'description': 'Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)', 'interventionNames': ['Drug: Chloroprocaine HCl 1%']}, {'type': 'EXPERIMENTAL', 'label': '4 mL Chloroprocaine HCl 1%', 'description': 'Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)', 'interventionNames': ['Drug: Chloroprocaine HCl 1%']}, {'type': 'EXPERIMENTAL', 'label': '5 mL Chloroprocaine HCl 1%', 'description': 'Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)', 'interventionNames': ['Drug: Chloroprocaine HCl 1%']}], 'interventions': [{'name': 'Chloroprocaine HCl 1%', 'type': 'DRUG', 'otherNames': ['Ampres 1%'], 'description': 'Intrathecal Route', 'armGroupLabels': ['3 mL Chloroprocaine HCl 1%', '4 mL Chloroprocaine HCl 1%', '5 mL Chloroprocaine HCl 1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Stefano Bonarelli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Stefano MD Bonarelli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sintetica SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cross S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}