Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-08 @ 6:03 AM
Study NCT ID:
NCT03695367
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Herniorrhaphy Study for Opioid Elimination
Sponsor:
Organization:
Raw JSON
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non-opioid multimodal analgesic (MMA) regimen.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 5, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 7, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Receiving no Opioid Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: HTX-011 + MMA Regimen', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.'}, {'id': 'OG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: HTX-011 + MMA Regimen', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.'}, {'id': 'OG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '2.141', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '4.199', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'MME, morphine milligram equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Percentge of Subjects Receiving no Opioid Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: HTX-011 + MMA Regimen', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.'}, {'id': 'OG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; 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non-opioid multimodal analgesic (MMA) regimen.'}, {'id': 'OG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: HTX-011 + MMA Regimen', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.'}, {'id': 'OG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: HTX-011 + MMA Regimen', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.'}, {'id': 'FG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Missed the Day 28 visit.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'One subject missed the Day 28 visit and one subject missed the Day 10 and Day 28 visits.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: HTX-011 + MMA Regimen', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.'}, {'id': 'BG001', 'title': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'spread': '13.52', 'groupId': 'BG000'}, {'value': '46.1', 'spread': '14.99', 'groupId': 'BG001'}, {'value': '48.7', 'spread': '14.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-31', 'size': 1470096, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-11T13:45', 'hasProtocol': True}, {'date': '2018-10-18', 'size': 1138552, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-11T13:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2020-04-05', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-01', 'studyFirstSubmitDate': '2018-10-01', 'dispFirstSubmitQcDate': '2020-04-05', 'resultsFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2018-10-02', 'dispFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-11', 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Receiving no Opioid Rescue', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])', 'timeFrame': '72 hours'}, {'measure': 'Percentge of Subjects Receiving no Opioid Rescue', 'timeFrame': '0-24 hours, 24-48 hours, 24-72 hours, 48-72 hours'}, {'measure': 'Percentge of Subjects Receiving no Opioid Rescue', 'timeFrame': 'Day 28'}, {'measure': 'Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.', 'timeFrame': '72 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['inguinal hernia', 'hernia', 'hernia surgery', 'postoperative pain', 'herniorrhaphy'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia.\n* Has an American Society of Anesthesiologists Physical Status of I, II, or III.\n* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.\n\nExclusion Criteria:\n\n* Had any prior inguinal hernia repair except as a child (less than 6 years of age).\n* Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).\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 medications.\n* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.\n* Has taken any NSAIDs within least 10 days prior to the scheduled surgery.\n* Has taken long-acting opioids within 3 days prior to the scheduled surgery.\n* Has taken any opioids within 24 hours prior to the 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.\n* Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.\n* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.\n* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.\n* As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).\n* Has uncontrolled anxiety, psychiatric, or neurological disorder.\n* Had a malignancy in the last year, with the exception of nonmetastatic 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 at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study.\n* Previously participated in an HTX-011 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 within 12 months.\n* Has a body mass index (BMI) \\>39 kg/m2.'}, 'identificationModule': {'nctId': 'NCT03695367', 'briefTitle': 'Phase 2 Herniorrhaphy Study for Opioid Elimination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heron Therapeutics'}, 'officialTitle': 'A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy', 'orgStudyIdInfo': {'id': 'HTX-011-215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: HTX-011 + MMA Regimen', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.', 'interventionNames': ['Drug: HTX-011', 'Device: Luer lock applicator', 'Device: Vial access device', 'Drug: Ibuprofen', 'Drug: Acetaminophen']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.', 'interventionNames': ['Drug: HTX-011', 'Device: Luer lock applicator', 'Device: Vial access device', 'Drug: Ibuprofen', 'Drug: Acetaminophen', 'Drug: Ketorolac']}], 'interventions': [{'name': 'HTX-011', 'type': 'DRUG', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.', 'armGroupLabels': ['Cohort 1: HTX-011 + MMA Regimen', 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac']}, {'name': 'Luer lock applicator', 'type': 'DEVICE', 'description': 'Applicator for instillation.', 'armGroupLabels': ['Cohort 1: HTX-011 + MMA Regimen', 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac']}, {'name': 'Vial access device', 'type': 'DEVICE', 'description': 'Device for withdrawal of drug product.', 'armGroupLabels': ['Cohort 1: HTX-011 + MMA Regimen', 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'Ibuprofen, 600 mg.', 'armGroupLabels': ['Cohort 1: HTX-011 + MMA Regimen', 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'description': 'Acetaminophen, 1 g.', 'armGroupLabels': ['Cohort 1: HTX-011 + MMA Regimen', 'Cohort 2: HTX-011 + MMA Regimen + Ketorolac']}, {'name': 'Ketorolac', 'type': 'DRUG', 'description': 'Intraoperative IV ketorolac.', 'armGroupLabels': ['Cohort 2: HTX-011 + MMA Regimen + Ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research, LLC', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Neil Singla, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lotus Clinical Research, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heron Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}