Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-24 @ 8:07 AM
Study NCT ID:
NCT03789318
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2018-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study in Subjects Undergoing Complete Abdominoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}}}, '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': 'D004091', 'term': 'Hydromorphone'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D003061', 'term': 'Codeine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nancy@concentricanalgesics.com', 'phone': '14154847921', 'title': 'Head of Clinical Operations', 'organization': 'Concentric Analgesics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)', 'eventGroups': [{'id': 'EG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008 reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008 reconstituted in saline.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008 reconstituted in saline.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lip oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Incision site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Airway complication of anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Flap necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Incision site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008 reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG002', 'title': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008 reconstituted in saline.'}, {'id': 'OG003', 'title': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008 reconstituted in saline.'}, {'id': 'OG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '2.22', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '3.10', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '1.96', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2912', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '96 hours', 'description': 'Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008 reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG002', 'title': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008 reconstituted in saline.'}, {'id': 'OG003', 'title': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008 reconstituted in saline.'}, {'id': 'OG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '392.98', 'spread': '138.191', 'groupId': 'OG000'}, {'value': '392.67', 'spread': '163.025', 'groupId': 'OG001'}, {'value': '384.94', 'spread': '136.551', 'groupId': 'OG002'}, {'value': '406.88', 'spread': '220.821', 'groupId': 'OG003'}, {'value': '356.23', 'spread': '175.969', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.4980', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 96 hours', 'description': 'Pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) from 0 to T96 hours', 'unitOfMeasure': 'score on a scale*hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Time to Opioid Cessation or Freedom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008 reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG002', 'title': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008 reconstituted in saline.'}, {'id': 'OG003', 'title': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008 reconstituted in saline.'}, {'id': 'OG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '56.37', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '216.65'}, {'value': '55.42', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '156.20'}, {'value': '83.89', 'groupId': 'OG002', 'lowerLimit': '0.95', 'upperLimit': '323.22'}, {'value': '59.55', 'groupId': 'OG003', 'lowerLimit': '1.13', 'upperLimit': '362.63'}, {'value': '42.26', 'groupId': 'OG004', 'lowerLimit': '1.02', 'upperLimit': '238.57'}]}]}], 'analyses': [{'pValue': '0.1958', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Surgery to Day 29', 'description': 'Time to the last use of opioid', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Percent of Opioid Free Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008 reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG002', 'title': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008 reconstituted in saline.'}, {'id': 'OG003', 'title': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008 reconstituted in saline.'}, {'id': 'OG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.9546', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 to 96 hours', 'description': 'Percent of subjects who were opioid free at 24-96 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Total Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008 reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'OG002', 'title': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008 reconstituted in saline.'}, {'id': 'OG003', 'title': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008 reconstituted in saline.'}, {'id': 'OG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '85.83', 'spread': '52.246', 'groupId': 'OG000'}, {'value': '96.67', 'spread': '63.134', 'groupId': 'OG001'}, {'value': '69.77', 'spread': '41.710', 'groupId': 'OG002'}, {'value': '58.00', 'spread': '69.170', 'groupId': 'OG003'}, {'value': '77.85', 'spread': '72.524', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.4434', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 96 hours', 'description': 'The sum of daily opioid consumption (in morphine equivalents)', 'unitOfMeasure': 'mg morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008 reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'FG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'FG002', 'title': 'CA-008 10 mg (0.1 mg/mL) Cohort 2', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008 reconstituted in saline.'}, {'id': 'FG003', 'title': 'CA-008 15 mg (0.15 mg/mL) Cohort 3', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008 reconstituted in saline.'}, {'id': 'FG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nCA-008 5 mg: 5 mg CA-008\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'BG001', 'title': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'BG002', 'title': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 10 mg: 10 mg CA-008'}, {'id': 'BG003', 'title': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery\n\nCA-008 15 mg: 15 mg CA-008'}, {'id': 'BG004', 'title': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).\n\nPlacebo: Each cohort will use placebo reconstituted in saline.\n\nBupivacaine Hydrochloride: 0.25% administered pre-surgery\n\nHydromorphone: 0.02 mg/kg IV administered intraoperatively\n\nFentanyl: 100 mcg IV administered intraoperatively\n\nAcetaminophen: 1000 mg IV administered intraoperatively\n\nOxycodone: 5-10 mg PO administered post-surgery'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '10.95', 'groupId': 'BG000'}, {'value': '38.2', 'spread': '7.17', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '10.27', 'groupId': 'BG002'}, {'value': '43.3', 'spread': '6.74', 'groupId': 'BG003'}, {'value': '38.3', 'spread': '8.76', 'groupId': 'BG004'}, {'value': '40.4', 'spread': '8.93', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}]}, {'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'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'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': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}]}, {'title': 'More than one race', '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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-28', 'size': 3393352, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-18T12:39', 'hasProtocol': True}, {'date': '2019-04-24', 'size': 781044, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-22T22:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'dispFirstSubmitDate': '2020-06-11', 'completionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2018-12-02', 'dispFirstSubmitQcDate': '2022-01-04', 'resultsFirstSubmitDate': '2021-08-12', 'studyFirstSubmitQcDate': '2018-12-26', 'dispFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-04', 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)', 'timeFrame': '96 hours', 'description': 'Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours'}], 'secondaryOutcomes': [{'measure': 'Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores', 'timeFrame': '0 to 96 hours', 'description': 'Pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) from 0 to T96 hours'}, {'measure': 'Time to Opioid Cessation or Freedom', 'timeFrame': 'From Surgery to Day 29', 'description': 'Time to the last use of opioid'}, {'measure': 'Percent of Opioid Free Subjects', 'timeFrame': '24 to 96 hours', 'description': 'Percent of subjects who were opioid free at 24-96 hours'}, {'measure': 'Total Opioid Consumption', 'timeFrame': '0 to 96 hours', 'description': 'The sum of daily opioid consumption (in morphine equivalents)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postsurgical Pain']}, 'descriptionModule': {'briefSummary': 'Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.', 'detailedDescription': 'This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel design study evaluating up to 4 ascending dose level cohorts, each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective C-ABD. Up to 72 subjects may be randomized in 4 cohorts.\n\nFor each subject, postsurgical assessments will be conducted in two parts:\n\n* Inpatient period: starts with completion of study treatment injection (T0) and continues through 96 hours (T96h).\n* Outpatient period: begins on discharge from the inpatient unit through various follow up visits to day 29 (D29)/week 4 (W4) after surgery. Note that additional follow up visits may occur at any time or even after D29/W4 to follow adverse events (AEs) to resolution or establishment of a new baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Plan to undergo an elective complete abdominoplasty (C-ABD), without collateral procedure or additional surgeries.\n* In the medical judgment of the investigator, be a reasonably healthy adult aged 18 - 65 years old, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization.\n* Unless the subject has a same sex partner, he or she must either be sterile (surgically or biologically) or commit to an acceptable method of birth control while participating in the study.\n* Have a body mass index ≤ 35 kg/m².\n* Be willing and able to sign the informed consent form (ICF) approved by an Institutional Review Board (IRB).\n\nKey Exclusion Criteria:\n\n* In the opinion of the Investigator, have a concurrent painful condition that may require analgesic treatment during the study period or may confound post-surgical pain assessments.\n* Have a known allergy to chili peppers, capsaicin or the components of CA-008, acetaminophen, bupivacaine, fentanyl hydromorphone or oxycodone.\n* As determined by the investigator have a history or clinical manifestation of significant medical, neuropsychiatric or other condition, including a clinically significant existing arrhythmia, left bundle branch block or abnormal ECG, myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.\n* The following are considered disallowed medications:\n\n 1. Be tolerant to opioids defined as those who have been receiving or have received chronic opioid therapy greater than 15 mg of oral morphine equivalents per day for greater than 3 out of 7 days per week over a one-month period within 6 months of screening.\n 2. Within 1 day prior to surgery and throughout the inpatient period, be taking any capsaicin-containing products, such as dietary supplements or over-the-counter (OTC) preparations, including topical formulations, and prescription medications.\n 3. Within the 7 days prior to surgery, be taking any central nervous system (CNS) active agent as an analgesic adjunct medication, such as anticonvulsants, antidepressants, benzodiazepines, sedative- hypnotics, clonidine and other central alpha-2 agents, ketamine or muscle relaxants.\n\n i. These drugs are permitted if prescribed for non-pain indications and the dose has been stable for at least 30 days prior to surgery.\n\nii. The use of benzodiazepines and the non-benzodiazepines are permitted to treat insomnia during the postoperative period.'}, 'identificationModule': {'nctId': 'NCT03789318', 'briefTitle': 'Study in Subjects Undergoing Complete Abdominoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concentric Analgesics'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty', 'orgStudyIdInfo': {'id': 'CA-PS-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'description': 'Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).', 'interventionNames': ['Drug: CA-008 5 mg', 'Drug: Bupivacaine Hydrochloride', 'Drug: Hydromorphone', 'Drug: Fentanyl', 'Drug: Acetaminophen', 'Drug: Oxycodone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for Cohort 1', 'description': 'Cohort 1:\n\nPlacebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).', 'interventionNames': ['Drug: Placebo', 'Drug: Bupivacaine Hydrochloride', 'Drug: Hydromorphone', 'Drug: Fentanyl', 'Drug: Acetaminophen', 'Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CA-008 10 mg (0.1 mg/mL)', 'description': 'Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).', 'interventionNames': ['Drug: Bupivacaine Hydrochloride', 'Drug: Hydromorphone', 'Drug: Fentanyl', 'Drug: Acetaminophen', 'Drug: Oxycodone', 'Drug: CA-008 10 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CA-008 15 mg (0.15 mg/mL)', 'description': 'Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).', 'interventionNames': ['Drug: Bupivacaine Hydrochloride', 'Drug: Hydromorphone', 'Drug: Fentanyl', 'Drug: Acetaminophen', 'Drug: Oxycodone', 'Drug: CA-008 15 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for Cohorts 2 and 3', 'description': 'Cohorts 2 \\& 3:\n\nPlacebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.\n\nThe surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).', 'interventionNames': ['Drug: Placebo', 'Drug: Bupivacaine Hydrochloride', 'Drug: Hydromorphone', 'Drug: Fentanyl', 'Drug: Acetaminophen', 'Drug: Oxycodone']}], 'interventions': [{'name': 'CA-008 5 mg', 'type': 'DRUG', 'otherNames': ['Vocacapsaicin'], 'description': '5 mg CA-008 reconstituted in saline.', 'armGroupLabels': ['CA-008 5 mg (0.05 mg/mL) Cohort 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Each cohort will use placebo reconstituted in saline.', 'armGroupLabels': ['Placebo for Cohort 1', 'Placebo for Cohorts 2 and 3']}, {'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'description': '0.25% administered pre-surgery', 'armGroupLabels': ['CA-008 10 mg (0.1 mg/mL)', 'CA-008 15 mg (0.15 mg/mL)', 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'Placebo for Cohort 1', 'Placebo for Cohorts 2 and 3']}, {'name': 'Hydromorphone', 'type': 'DRUG', 'description': '0.02 mg/kg IV administered intraoperatively', 'armGroupLabels': ['CA-008 10 mg (0.1 mg/mL)', 'CA-008 15 mg (0.15 mg/mL)', 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'Placebo for Cohort 1', 'Placebo for Cohorts 2 and 3']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': '100 mcg IV administered intraoperatively', 'armGroupLabels': ['CA-008 10 mg (0.1 mg/mL)', 'CA-008 15 mg (0.15 mg/mL)', 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'Placebo for Cohort 1', 'Placebo for Cohorts 2 and 3']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'description': '1000 mg IV administered intraoperatively', 'armGroupLabels': ['CA-008 10 mg (0.1 mg/mL)', 'CA-008 15 mg (0.15 mg/mL)', 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'Placebo for Cohort 1', 'Placebo for Cohorts 2 and 3']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': '5-10 mg PO administered post-surgery', 'armGroupLabels': ['CA-008 10 mg (0.1 mg/mL)', 'CA-008 15 mg (0.15 mg/mL)', 'CA-008 5 mg (0.05 mg/mL) Cohort 1', 'Placebo for Cohort 1', 'Placebo for Cohorts 2 and 3']}, {'name': 'CA-008 10 mg', 'type': 'DRUG', 'otherNames': ['Vocacapsaicin'], 'description': '10 mg CA-008 reconstituted in saline.', 'armGroupLabels': ['CA-008 10 mg (0.1 mg/mL)']}, {'name': 'CA-008 15 mg', 'type': 'DRUG', 'otherNames': ['Vocacapsaicin'], 'description': '15 mg CA-008 reconstituted in saline.', 'armGroupLabels': ['CA-008 15 mg (0.15 mg/mL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research, LLC', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Alina Beaton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lotus Clinical Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concentric Analgesics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}