Viewing Study NCT03015532

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Ignite Creation Date: 2025-12-24 @ 9:38 PM
Ignite Modification Date: 2026-01-02 @ 12:50 PM
Study NCT ID: NCT03015532
Status: COMPLETED
Last Update Posted: 2025-03-07
First Post: 2017-01-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'svisonneau@herontx.com', 'phone': '858-251-7232', 'title': 'Vice President, Clinical Operations', 'organization': 'Heron Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 Days.', 'description': 'Subjects reporting more than one TEAE are counted only once.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1, Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1, Group 2: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation(combination).', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Cohort 1, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 1, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Cohort 2, Group 1: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 55, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Cohort 2, Group 2: HTX-011 + Ropivacaine', 'description': 'HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 50, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Cohort 2, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 50, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Cohort 2, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 49, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 29}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 30}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 25}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 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'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 48 Hours Postsurgery (AUC0-48).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1, Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.'}, {'id': 'OG001', 'title': 'Cohort 1, Group 2: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).'}, {'id': 'OG002', 'title': 'Cohort 1, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'OG003', 'title': 'Cohort 1, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.'}, {'id': 'OG004', 'title': 'Cohort 2, Group 1: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.'}, {'id': 'OG005', 'title': 'Cohort 2, Group 2: HTX-011 + Ropivacaine', 'description': 'HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.'}, {'id': 'OG006', 'title': 'Cohort 2, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'OG007', 'title': 'Cohort 2, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '386.12', 'spread': '82.930', 'groupId': 'OG000'}, {'value': '391.56', 'spread': '84.450', 'groupId': 'OG001'}, {'value': '405.82', 'spread': '97.549', 'groupId': 'OG002'}, {'value': '347.56', 'spread': '103.422', 'groupId': 'OG003'}, {'value': '322.08', 'spread': '99.669', 'groupId': 'OG004'}, {'value': '307.25', 'spread': '127.674', 'groupId': 'OG005'}, {'value': '396.36', 'spread': '77.468', 'groupId': 'OG006'}, {'value': '352.74', 'spread': '100.887', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-48 is 0-480.', 'unitOfMeasure': 'pain intensity score*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 72 Hours Postsurgery (AUC0-72).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1, Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.'}, {'id': 'OG001', 'title': 'Cohort 1, Group 2: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).'}, {'id': 'OG002', 'title': 'Cohort 1, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'OG003', 'title': 'Cohort 1, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.'}, {'id': 'OG004', 'title': 'Cohort 2, Group 1: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.'}, {'id': 'OG005', 'title': 'Cohort 2, Group 2: HTX-011 + Ropivacaine', 'description': 'HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.'}, {'id': 'OG006', 'title': 'Cohort 2, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'OG007', 'title': 'Cohort 2, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '543.14', 'spread': '142.566', 'groupId': 'OG000'}, {'value': '560.85', 'spread': '136.099', 'groupId': 'OG001'}, {'value': '576.44', 'spread': '150.815', 'groupId': 'OG002'}, {'value': '468.58', 'spread': '179.687', 'groupId': 'OG003'}, {'value': '471.19', 'spread': '149.443', 'groupId': 'OG004'}, {'value': '452.54', 'spread': '194.095', 'groupId': 'OG005'}, {'value': '577.93', 'spread': '125.102', 'groupId': 'OG006'}, {'value': '516.93', 'spread': '152.512', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720.', 'unitOfMeasure': 'pain intensity score*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1, Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.'}, {'id': 'OG001', 'title': 'Cohort 1, Group 2: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).'}, {'id': 'OG002', 'title': 'Cohort 1, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'OG003', 'title': 'Cohort 1, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.'}, {'id': 'OG004', 'title': 'Cohort 2, Group 1: HTX-011', 'description': 'HTX-011, 400 mg/12 mg via instillation.'}, {'id': 'OG005', 'title': 'Cohort 2, Group 2: HTX-011 + Ropivacaine', 'description': 'HTX-011, 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.'}, {'id': 'OG006', 'title': 'Cohort 2, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'OG007', 'title': 'Cohort 2, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.53', 'spread': '31.615', 'groupId': 'OG000'}, {'value': '66.86', 'spread': '31.154', 'groupId': 'OG001'}, {'value': '70.41', 'spread': '18.057', 'groupId': 'OG002'}, {'value': '60.70', 'spread': '29.903', 'groupId': 'OG003'}, {'value': '64.39', 'spread': '27.889', 'groupId': 'OG004'}, {'value': '60.32', 'spread': '34.949', 'groupId': 'OG005'}, {'value': '73.55', 'spread': '34.448', 'groupId': 'OG006'}, {'value': '68.35', 'spread': '29.169', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'morphine milligram equivalent (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1, Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.'}, {'id': 'FG001', 'title': 'Cohort 1, Group 2: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).'}, {'id': 'FG002', 'title': 'Cohort 1, Group 3: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'FG003', 'title': 'Cohort 1, Group 4: 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'numSubjects': '56'}, {'groupId': 'FG006', 'numSubjects': '53'}, {'groupId': 'FG007', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '58'}, {'groupId': 'FG005', 'numSubjects': '54'}, {'groupId': 'FG006', 'numSubjects': '51'}, {'groupId': 'FG007', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}, {'value': '53', 'groupId': 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'2021-06-11', 'studyFirstSubmitQcDate': '2017-01-06', 'dispFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-29', 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 48 Hours Postsurgery (AUC0-48).', 'timeFrame': '48 hours', 'description': 'Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-48 is 0-480.'}], 'secondaryOutcomes': [{'measure': 'Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 72 Hours Postsurgery (AUC0-72).', 'timeFrame': '72 hours', 'description': 'Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720.'}, {'measure': 'Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)', 'timeFrame': '72 hours'}]}, 'conditionsModule': {'keywords': ['knee', 'knee replacement', 'arthroplasty', 'joint replacement', 'knee pain'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '32561266', 'type': 'DERIVED', 'citation': 'Lachiewicz PF, Lee GC, Pollak RA, Leiman DG, Hu J, Sah AP. HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial. J Arthroplasty. 2020 Oct;35(10):2843-2851. doi: 10.1016/j.arth.2020.05.044. Epub 2020 May 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is scheduled to undergo primary unilateral TKA under general anesthesia.\n* Has not previously undergone TKA in either knee.\n* Has an American Society of Anesthesiologists Physical Status of I, II, or III.\n* Is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance.\n* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.\n\nExclusion Criteria:\n\n* Has a planned concurrent surgical procedure (eg, bilateral TKA).\n* Has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain.\n* Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications.\n* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.\n* Has taken NSAIDs within 10 days prior to the scheduled surgery.\n* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).\n* Has been administered bupivacaine within 5 days prior to the scheduled surgery.\n* Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.\n* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.\n* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.\n* Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.\n* Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.\n* Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. Has any chronic condition or disease that would compromise neurological or vascular assessments.\n* Had a malignancy in the last year, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.\n* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.\n* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.\n* Has undergone 3 or more surgeries within 12 months.\n* Has a body mass index (BMI) \\>38 kg/m2.'}, 'identificationModule': {'nctId': 'NCT03015532', 'briefTitle': 'Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heron Therapeutics'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'HTX-011-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation', 'interventionNames': ['Drug: HTX-011']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Group 2: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination)', 'interventionNames': ['Drug: HTX-011']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 1, Group 3: Saline Placebo', 'description': 'Saline placebo via injection', 'interventionNames': ['Drug: Saline Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1, Group 4: Bupivacaine HCI', 'description': 'Bupivacaine HCl without epinephrine, 125 mg via injection', 'interventionNames': ['Drug: Bupivicaine HCl']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation', 'interventionNames': ['Drug: HTX-011']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Group 2: HTX-011 + Ropivacaine', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; 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