Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-07-21 @ 11:07 AM
Study NCT ID:
NCT03853694
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2018-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MedInfo@pacira.com', 'phone': '1-855-793-9727', 'title': 'Pacira Medical Information', 'organization': 'Pacira Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'Results conducted at Site shall not be published before 1st multicenter publication by Sponsor but can proceed if there is no such publication ≤18 months after study completion/termination at all sites and all data have been received. Before submitting manuscript/materials to an outside person/entity, site shall give Sponsor 60 days to review and comment. Site shall, upon request, further delay publication/presentation for ≤120 days to allow Sponsor to protect its interests in Inventions.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration\n\n150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 43, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.\n\n50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 41, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.\n\nExparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 30, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Incision site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 74, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 20, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Postpartum hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal wall hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Incision Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Postsurgical Opioid Consumption Through 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration\n\n150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.'}, {'id': 'OG001', 'title': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.\n\n50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}, {'id': 'OG002', 'title': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.\n\nExparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '22.1', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Through 72 hours post-surgery', 'description': 'To Compare total opioid consumption through 72 hours following EXPAREL infiltration into the Transversus abdominus plane (TAP) with SOC in subjects undergoing an elective C-section', 'unitOfMeasure': 'OMED mg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Opioid-free Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration\n\n150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.'}, {'id': 'OG001', 'title': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.\n\n50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}, {'id': 'OG002', 'title': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.\n\nExparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '28.8', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through 72 hours or hospital discharge, whichever came first', 'description': 'Percentage of opioid-free subjects. LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables.', 'unitOfMeasure': 'percentage of participants, opioid free', 'reportingStatus': 'POSTED', 'populationDescription': 'LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables.'}, {'type': 'SECONDARY', 'title': 'Severity of Itching (Numeric Rating Scale Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration\n\n150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.'}, {'id': 'OG001', 'title': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.\n\n50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}, {'id': 'OG002', 'title': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.\n\nExparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.176', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '0.167', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'through 72 hours after surgery', 'description': 'Severity of itching (Numeric Rating Scale score from 0(being none)-10(being the worst))', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Related Symptom Distress Scale Score (ORSDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration\n\n150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.'}, {'id': 'OG001', 'title': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.\n\n50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}, {'id': 'OG002', 'title': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.\n\nExparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.051', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'through 72 hours after surgery', 'description': 'The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 10 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 10 symptom-specific scores. Each question will receive a score from 0-4 the composite score for each subject is the average of all scores. A higher score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration\n\n150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.'}, {'id': 'FG001', 'title': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.\n\n50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}, {'id': 'FG002', 'title': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.\n\nExparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Delivered early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'not suitable to proceed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'difficult surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration\n\n150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.'}, {'id': 'BG001', 'title': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.\n\n50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}, {'id': 'BG002', 'title': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.\n\nExparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.2', 'spread': '4.67', 'groupId': 'BG000'}, {'value': '34.1', 'spread': '4.93', 'groupId': 'BG001'}, {'value': '32.7', 'spread': '5.03', 'groupId': 'BG002'}, {'value': '33.3', 'spread': '4.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'American Society of Anesthesiologists (ASA) Physical Status Classification', 'classes': [{'categories': [{'title': 'ASA I', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'ASA II', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}, {'title': 'ASA III', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA I: normal, healthy patient ASA II: mild systemic disease ASA III Severe systemic disease that is not life threatening ASA IV: Severe systemic disease that is a constant threat to life', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (pre-pregnancy)', 'classes': [{'categories': [{'measurements': [{'value': '31.69', 'spread': '5.091', 'groupId': 'BG000'}, {'value': '31.08', 'spread': '5.181', 'groupId': 'BG001'}, {'value': '32.23', 'spread': '6.179', 'groupId': 'BG002'}, {'value': '31.68', 'spread': '5.490', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-07', 'size': 1802134, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-27T14:50', 'hasProtocol': True}, {'date': '2020-03-16', 'size': 3608412, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-26T16:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2018-09-19', 'resultsFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-15', 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Postsurgical Opioid Consumption Through 72 Hours', 'timeFrame': 'Through 72 hours post-surgery', 'description': 'To Compare total opioid consumption through 72 hours following EXPAREL infiltration into the Transversus abdominus plane (TAP) with SOC in subjects undergoing an elective C-section'}], 'secondaryOutcomes': [{'measure': 'Percentage of Opioid-free Subjects', 'timeFrame': 'through 72 hours or hospital discharge, whichever came first', 'description': 'Percentage of opioid-free subjects. LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables.'}, {'measure': 'Severity of Itching (Numeric Rating Scale Score)', 'timeFrame': 'through 72 hours after surgery', 'description': 'Severity of itching (Numeric Rating Scale score from 0(being none)-10(being the worst))'}, {'measure': 'Opioid Related Symptom Distress Scale Score (ORSDS)', 'timeFrame': 'through 72 hours after surgery', 'description': 'The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 10 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 10 symptom-specific scores. Each question will receive a score from 0-4 the composite score for each subject is the average of all scores. A higher score indicates a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bupivacaine', 'EXPAREL', 'analgesic', 'TAP Block', 'C-Section', 'Cesarean Section', 'elective c-section', 'TAP'], 'conditions': ['Elective Cesarean Section', 'Pain Management']}, 'referencesModule': {'references': [{'pmid': '34626927', 'type': 'DERIVED', 'citation': 'Habib AS, Nedeljkovic SS, Horn JL, Smiley RM, Kett AG, Vallejo MC, Song J, Scranton R, Bao X. Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine. J Clin Anesth. 2021 Dec;75:110527. doi: 10.1016/j.jclinane.2021.110527. Epub 2021 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare total opioid consumption by subjects in different treatment groups.\n\nAnother purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.', 'detailedDescription': 'This is a Phase-4, multicenter, randomized, active-controlled study in approximately 182 adult women undergoing elective C-section. All subjects will remain in the hospital for up to 72 hours post surgery.\n\nSubjects will be screened within 30 days prior to surgery. During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation.\n\nAfter the Informed Consent Form (ICF) is signed, a medical history, surgical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, alcohol breath test and urine drug screen, and clinical laboratory tests (hematology and chemistry) will be performed.\n\nOn Day 1, prior to the C-section, eligible subjects will be randomized in a 1:1:1 ratio into one of the three treatment groups listed below:\n\n* Group 1: 150 mcg Duramorph® (SOC arm)+ postoperative multi-modal pain regimen as defined in this protocol. No EXPAREL TAP infiltration following skin-incision closure.\n* Group 2: 50 mcg Duramorph + EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol.\n* Group 3: EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol. No Duramorph.\n\nRescue Medication will be provided, as needed, for all subjects.\n\nSubjects will remain in the hospital for up to 72 hours after surgery.\n\nTotal opioid burden and Pain intensity scores using a 10 cm Visual Analog Scale (VAS) will be collected.\n\nDaily pain intensity score (VAS) and all pain medications will be collected through Day 14.\n\nA phone call will be made to each subject on Day 14 and Day 30.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Females 18 years of age and older at screening.\n2. Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.\n3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.\n4. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.\n\nExclusion Criteria:\n\n1. Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.\n2. Subjects with a pregnancy-induced medical condition or complication.\n3. Subjects with 3 or more prior C-sections.\n4. Pre-pregnancy body mass index \\>50 kg/m2.\n5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.\n6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.\n7. Severely impaired renal or hepatic function.\n8. Subjects at an increased risk for bleeding or a coagulation disorder.\n9. Concurrent painful physical condition that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the surgery.\n10. Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate.\n11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n12. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug.\n13. Previous participation in an EXPAREL study.\n14. Any clinically significant event or condition uncovered during the surgery that might render the subject medically unstable or complicate the subject's postsurgical course.\n15. Receives the epidural component of combined spinal epidural (CSE) anesthesia during the study."}, 'identificationModule': {'nctId': 'NCT03853694', 'acronym': 'CHOICE', 'briefTitle': 'Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacira Pharmaceuticals, Inc'}, 'officialTitle': 'A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)', 'orgStudyIdInfo': {'id': '402-C-414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (Standard of Care Group)', 'description': '150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration', 'interventionNames': ['Drug: 150 mcg Duramorph + multi-modal pain regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Duramorph + EXPAREL TAP)', 'description': '50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.', 'interventionNames': ['Drug: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (EXPAREL TAP)', 'description': 'EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.', 'interventionNames': ['Drug: Exparel TAP + multi-modal pain regimen']}], 'interventions': [{'name': '50 mcg Duramorph+ EXPAREL + multi-modal pain regimen', 'type': 'DRUG', 'description': 'Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.', 'armGroupLabels': ['Group 2 (Duramorph + EXPAREL TAP)']}, {'name': '150 mcg Duramorph + multi-modal pain regimen', 'type': 'DRUG', 'description': 'Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.', 'armGroupLabels': ['Group 1 (Standard of Care Group)']}, {'name': 'Exparel TAP + multi-modal pain regimen', 'type': 'DRUG', 'description': 'EXPAREL administered via TAP infiltration + multi-modal pain regimen.', 'armGroupLabels': ['Group 3 (EXPAREL TAP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida- Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida college of Medicine - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Clinical Research Prime', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Peter's University Medical Center", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/NY Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee-Women's Hospital of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77555-0877', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Health System', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '86506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Nayana Nagaraj, MD, PhD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pacira Pharmaceuticals, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}