Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-25 @ 3:00 AM
Study NCT ID:
NCT03011333
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2B Upper Extremity Nerve Block Study
Sponsor:
Organization:
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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, '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 Treatment Emergent Adverse Event (TEAE) are counted only once.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 21, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Group 4: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 43, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 5: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 47, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Group 6: Bupivacaine HCl', 'description': 'Bupivacaine HCl without epinephrine, 50 mg via nerve block', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 33, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Group 7: Saline Placebo', 'description': 'Saline placebo via nerve block', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 35, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 37}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 25}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Medical device site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Product Issues', '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 With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block'}, {'id': 'OG001', 'title': 'Group 2: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block'}, {'id': 'OG002', 'title': 'Group 3: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block'}, {'id': 'OG003', 'title': 'Group 4: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block'}, {'id': 'OG004', 'title': 'Group 5: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation'}, {'id': 'OG005', 'title': 'Group 6: Bupivacaine HCl', 'description': 'Bupivacaine HCl without epinephrine, 50 mg via nerve block'}, {'id': 'OG006', 'title': 'Group 7: Saline Placebo', 'description': 'Saline placebo via nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '124.51', 'spread': '59.462', 'groupId': 'OG000'}, {'value': '136.17', 'spread': '58.598', 'groupId': 'OG001'}, {'value': '136.76', 'spread': '56.034', 'groupId': 'OG002'}, {'value': '116.71', 'spread': '52.622', 'groupId': 'OG003'}, {'value': '114.87', 'spread': '48.214', 'groupId': 'OG004'}, {'value': '133.83', 'spread': '49.493', 'groupId': 'OG005'}, {'value': '151.52', 'spread': '46.213', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Pain intensity is assessed 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 AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.', 'unitOfMeasure': 'pain intensity score*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block'}, {'id': 'OG001', 'title': 'Group 2: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block'}, {'id': 'OG002', 'title': 'Group 3: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block'}, {'id': 'OG003', 'title': 'Group 4: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block'}, {'id': 'OG004', 'title': 'Group 5: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation'}, {'id': 'OG005', 'title': 'Group 6: Bupivacaine HCl', 'description': 'Bupivacaine HCl without epinephrine, 50 mg via nerve block'}, {'id': 'OG006', 'title': 'Group 7: Saline Placebo', 'description': 'Saline placebo via nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '38.71', 'spread': '28.650', 'groupId': 'OG000'}, {'value': '24.39', 'spread': '19.878', 'groupId': 'OG001'}, {'value': '38.00', 'spread': '19.452', 'groupId': 'OG002'}, {'value': '28.84', 'spread': '22.603', 'groupId': 'OG003'}, {'value': '37.46', 'spread': '21.452', 'groupId': 'OG004'}, {'value': '33.57', 'spread': '23.088', 'groupId': 'OG005'}, {'value': '36.38', 'spread': '23.275', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 Hours', 'unitOfMeasure': 'Morphine milligram equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block'}, {'id': 'FG001', 'title': 'Group 2: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block'}, {'id': 'FG002', 'title': 'Group 3: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block'}, {'id': 'FG003', 'title': 'Group 4: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block'}, {'id': 'FG004', 'title': 'Group 5: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation'}, {'id': 'FG005', 'title': 'Group 6: Bupivacaine HCl', 'description': 'Bupivacaine HCl without epinephrine, 50 mg via nerve block'}, {'id': 'FG006', 'title': 'Group 7: Saline Placebo', 'description': 'Saline placebo via nerve block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '41'}, {'groupId': 'FG006', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '37'}, {'groupId': 'FG006', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'A total of 243 subjects received study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '243', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block'}, {'id': 'BG001', 'title': 'Group 2: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block'}, {'id': 'BG002', 'title': 'Group 3: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block'}, {'id': 'BG003', 'title': 'Group 4: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block'}, {'id': 'BG004', 'title': 'Group 5: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation'}, {'id': 'BG005', 'title': 'Group 6: Bupivacaine HCl', 'description': 'Bupivacaine HCl without epinephrine, 50 mg via nerve block'}, {'id': 'BG006', 'title': 'Group 7: Saline Placebo', 'description': 'Saline placebo via nerve block'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '243', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '6.56', 'groupId': 'BG000'}, {'value': '32.1', 'spread': '8.51', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '5.64', 'groupId': 'BG002'}, {'value': '30.9', 'spread': '8.08', 'groupId': 'BG003'}, {'value': '32.0', 'spread': '8.64', 'groupId': 'BG004'}, {'value': '30.4', 'spread': '7.75', 'groupId': 'BG005'}, {'value': '31.3', 'spread': '9.03', 'groupId': 'BG006'}, {'value': '31.2', 'spread': '8.01', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '243', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '94', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '149', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '36', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '194', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '243', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-15', 'size': 1626544, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-14T11:34', 'hasProtocol': True}, {'date': '2018-01-04', 'size': 914718, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-14T11:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2018-06-08', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2017-01-03', 'dispFirstSubmitQcDate': '2018-06-08', 'resultsFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2017-01-03', 'dispFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-01', 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).', 'timeFrame': '24 hours', 'description': 'Pain intensity is assessed 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 AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.'}], 'secondaryOutcomes': [{'measure': 'Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)', 'timeFrame': '72 Hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 cc, inclusive. Note: textured implants are not allowed.\n* Has an American Society of Anesthesiologists Physical Status of I, II, or III.\n* 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.\n* Has a planned reconstructive procedure status post breast cancer therapy.\n* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.\n* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medication.\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 scheduled surgery.\n* Has been administered bupivacaine within 5 days prior to the scheduled surgery.\n* Has been administered any local anesthetic within 72 hours prior to the scheduled surgery other than to treat an AE that occurs after signing the ICF or for pretreatment prior to a needle placement.\n* Has initiated treatment with any of the following medications within 1 month prior to study drug administration or is taking any of these medications to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 (COX-2) inhibitors. (Note: If a subject is taking one of these medications for a reason other than pain control, she must be on a stable scheduled dose \\[ie, not "as needed"\\] for at least 1 month prior to study drug administration.) Anxiolytics prior to surgery are permitted, if necessary.\n* Has a medical condition 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, Hepatitis C, or human immunodeficiency virus (HIV).\n* Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments\n* Has any chronic neuromuscular deficit of either pectoral nerve function or arm/shoulder/truncal musculature.\n* 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. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.\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 in 12 months.\n* Has a body mass index (BMI) \\>35 kg/m2.'}, 'identificationModule': {'nctId': 'NCT03011333', 'briefTitle': 'Phase 2B Upper Extremity Nerve Block Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heron Therapeutics'}, 'officialTitle': 'A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty', 'orgStudyIdInfo': {'id': 'HTX-011-211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block.', 'interventionNames': ['Drug: HTX-011']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block.', 'interventionNames': ['Drug: HTX-011']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: HTX-011', 'description': 'HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block.', 'interventionNames': ['Drug: HTX-011']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block.', 'interventionNames': ['Drug: HTX-011']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: HTX-011', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation.', 'interventionNames': ['Drug: HTX-011']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 6: Bupivacaine HCl', 'description': 'Bupivacaine HCl without epinephrine, 50 mg via nerve block.', 'interventionNames': ['Drug: Bupivacaine HCl without epinephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 7: Saline Placebo', 'description': 'Saline placebo via nerve block.', 'interventionNames': ['Drug: Saline Placebo']}], 'interventions': [{'name': 'HTX-011', 'type': 'DRUG', 'description': 'HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.', 'armGroupLabels': ['Group 1: HTX-011', 'Group 2: HTX-011', 'Group 3: HTX-011', 'Group 4: HTX-011', 'Group 5: HTX-011']}, {'name': 'Bupivacaine HCl without epinephrine', 'type': 'DRUG', 'description': 'Bupivacaine HCl without epinephrine, 50 mg via nerve block.', 'armGroupLabels': ['Group 6: Bupivacaine HCl']}, {'name': 'Saline Placebo', 'type': 'DRUG', 'description': 'Saline placebo via nerve block.', 'armGroupLabels': ['Group 7: Saline Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heron Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}