Viewing Study NCT00974350

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Ignite Creation Date: 2025-12-24 @ 5:21 PM
Ignite Modification Date: 2025-12-30 @ 12:05 AM
Study NCT ID: NCT00974350
Status: COMPLETED
Last Update Posted: 2021-05-27
First Post: 2009-09-08
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deborah.scott@durect.com', 'phone': '408-777-1417', 'title': 'Deborah Scott', 'organization': 'Durect Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, approximately 14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine /Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 44, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine /Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine (660 mg) /Once', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 44, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 7}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Application site discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 10}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 16}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Incision site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Postoperative wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity on Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'OG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine /Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'OG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '-0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.353', 'groupDescription': 'Pain Intensity on Movement AUCs1-72 hours Including Pain Assessed Upon Taking Opioid Rescue - ITT', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS Mean difference from SABER-Placebo'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 to 72 hours post-dose', 'description': 'Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (patients with data available)'}, {'type': 'PRIMARY', 'title': 'Proportion (Percent) of Patients Using Supplemental Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'OG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine /Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'OG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0909', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Proportion of Patients Not Taking Any Supplemental Opioid Analgesic Medication', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled study sites'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 14 days post-dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (patients with data available)'}, {'type': 'SECONDARY', 'title': 'Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'OG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'OG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.30', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 to 48 hours post-dose', 'description': 'Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (patients with data available)'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'OG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine /Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'OG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very Dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Slightly Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Slightly Satisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'Very Satisfied', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Slightly Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Slightly Satisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'Very Satisfied', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Slightly Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Slightly Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}, {'title': 'Very Satisfied', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Slightly Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Slightly Satisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'Very Satisfied', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Slightly Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Slightly Satisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'Very Satisfied', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 to 5 days post-dose', 'description': 'Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (patients with data available)'}, {'type': 'SECONDARY', 'title': 'Supplemental Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'OG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine /Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'OG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '25.36', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '17.63', 'groupId': 'OG001'}, {'value': '38.4', 'spread': '60.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 14 days post-dose', 'unitOfMeasure': 'Total morphine equivalent dose (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (patients with data available)'}, {'type': 'SECONDARY', 'title': 'Mean Function Activities (Modified Brief Pain Inventory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'OG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine /Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'OG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once'}], 'classes': [{'title': 'get out of bed (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.63', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '3.49', 'groupId': 'OG002'}]}]}, {'title': 'get out of bed (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.88', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '2.50', 'groupId': 'OG002'}]}]}, {'title': 'get out of bed (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '2.01', 'groupId': 'OG002'}]}]}, {'title': 'get out of bed (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'get out of bed (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.60', 'groupId': 'OG002'}]}]}, {'title': 'Ability to walk (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.74', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '3.14', 'groupId': 'OG002'}]}]}, {'title': 'Ability to walk (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '2.35', 'groupId': 'OG002'}]}]}, {'title': 'Ability to walk (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.77', 'groupId': 'OG002'}]}]}, {'title': 'Ability to walk (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.45', 'groupId': 'OG002'}]}]}, {'title': 'Ability to walk (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.46', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Interact With Visitors (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.59', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Interact With Visitors (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Interact With Visitors (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.63', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Interact With Visitors (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.21', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Interact With Visitors (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Fall Asleep (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '2.09', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Fall Asleep (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.92', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Fall Asleep (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Fall Asleep (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.21', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Fall Asleep (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.45', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Stay Asleep (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '2.28', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Stay Asleep (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.01', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Stay Asleep (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.50', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Stay Asleep (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.33', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Stay Asleep (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Eat (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.58', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Eat (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.04', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Eat (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Eat (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Eat (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Deep Breath (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.32', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Deep Breath (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.82', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Deep Breath (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Deep Breath (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.56', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Deep Breath (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Cough (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '3.10', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '3.06', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Cough (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.61', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '2.99', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Cough (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.28', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '3.12', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Cough (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.97', 'groupId': 'OG002'}]}]}, {'title': 'Ability To Cough (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '2.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 to 5 days post-dose', 'description': 'In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (patients with data available)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'FG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'FG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once (SABER-Placebo 2.5 mL or 5.0 mL, as randomly assigned)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once'}, {'id': 'BG001', 'title': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine/Once\n\nSABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once'}, {'id': 'BG002', 'title': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once\n\nSABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '11.82', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '13.04', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '9.26', 'groupId': 'BG002'}, {'value': '48.11', 'spread': '11.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '3.74', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '2.92', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '3.68', 'groupId': 'BG002'}, {'value': '26.55', 'spread': '3.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'safety population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2009-09-08', 'resultsFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2009-09-09', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-11', 'studyFirstPostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity on Movement', 'timeFrame': '1 to 72 hours post-dose', 'description': 'Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.'}, {'measure': 'Proportion (Percent) of Patients Using Supplemental Opioids', 'timeFrame': '0 to 14 days post-dose'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '1 to 48 hours post-dose', 'description': 'Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.'}, {'measure': 'Treatment Satisfaction', 'timeFrame': '1 to 5 days post-dose', 'description': 'Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied).'}, {'measure': 'Supplemental Opioid Use', 'timeFrame': '0 to 14 days post-dose'}, {'measure': 'Mean Function Activities (Modified Brief Pain Inventory)', 'timeFrame': '1 to 5 days post-dose', 'description': 'In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-operative pain', 'hernia surgery', 'opioid'], 'conditions': ['Postoperative Pain', 'Hernia', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '22510183', 'type': 'RESULT', 'citation': 'Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.\n\nThe purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18 to 65 years of age, scheduled for hernia repair surgery\n* Patients must be in good health prior to study participation\n* Patients must have blood pressure within normal range or with Stage 1 high blood pressure\n* Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed\n* Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial\n* Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures\n\nExclusion Criteria:\n\n* Patients with previous abdominal surgery scar tissue\n* Patients with clinically significant abnormalities of any body system unrelated to the disease under study\n* Connective tissue disorders\n* Patients who are pregnant or lactating\n* Current or regular use of analgesic medication for other indications\n* Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening\n* Use of any drugs or medication that may interfere with the study and its results\n* Patients with known hypersensitivity to the study drugs or their components\n* Patients with known or suspected alcohol abuse or illicit drug use\n* Participation in another clinical trial at the same time or within 30 days of this trial\n* Patient is unwilling to comply with the study procedures'}, 'identificationModule': {'nctId': 'NCT00974350', 'briefTitle': 'A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Durect'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Pharmacodynamic and Pharmacokinetic Dose Response Study of SABER-Bupivacaine Instilled Into the Wound in Patients Undergoing Open Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'CLIN803-006-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: SABER-Bupivacaine', 'description': '2.5 mL SABER-Bupivacaine/Once', 'interventionNames': ['Drug: SABER-Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: SABER-Bupivacaine', 'description': '5.0 mL SABER-Bupivacaine/Once', 'interventionNames': ['Drug: SABER-Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3: SABER-Placebo', 'description': '2.5 mL or 5.0 mL SABER-Placebo/Once', 'interventionNames': ['Drug: SABER-Placebo']}], 'interventions': [{'name': 'SABER-Bupivacaine', 'type': 'DRUG', 'description': 'Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once', 'armGroupLabels': ['Group 1: SABER-Bupivacaine']}, {'name': 'SABER-Bupivacaine', 'type': 'DRUG', 'otherNames': ['POSIMIR® bupivacaine solution'], 'description': 'Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once', 'armGroupLabels': ['Group 2: SABER-Bupivacaine']}, {'name': 'SABER-Placebo', 'type': 'DRUG', 'description': 'Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once', 'armGroupLabels': ['Group 3: SABER-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4870', 'city': 'Cairns', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -16.92366, 'lon': 145.76613}}, {'zip': '4109', 'city': 'Sunnybank', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.58003, 'lon': 153.06064}}, {'zip': '5606', 'city': 'Port Lincoln', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -34.72625, 'lon': 135.87442}}, {'zip': '3135', 'city': 'Ringwood East', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.81667, 'lon': 145.25}}, {'city': 'Hamilton', 'country': 'New Zealand', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'overallOfficials': [{'name': 'Dmitri Lissin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Durect'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Durect', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nycomed', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dmitri Lissin, MD, Sr. Director Clinical Research', 'oldOrganization': 'Durect Corporation'}}}}