Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-28 @ 10:49 AM
Study NCT ID:
NCT04254692
Status:
TERMINATED
Last Update Posted:
2024-08-07
First Post:
2019-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimizing Recovery in Abdominoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-16', '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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rao@surgery.wisc.edu', 'phone': '(608) 263-1223', 'title': 'Venkat Rao, MD, MBA', 'organization': 'University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'study terminated early, not powered for meaningful results'}}, 'adverseEventsModule': {'timeFrame': 'up to 1 week post op', 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Use at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours postoperatively', 'description': 'Amount of opioids used postoperatively, measured in morphine equivalents', 'unitOfMeasure': 'morphine milligram equivalents', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Recovery-40 (QOR-40) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours postoperatively', 'description': 'The QOR-40 is a 40 item survey about the quality of recovery with a total possible range of scores from 40 to 200 where the higher the score the higher quality the recovery.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score Postoperative Day 1 (POD 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours postoperatively', 'description': 'The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score 1 Week Postop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week postoperatively', 'description': 'The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Use at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week postoperatively', 'description': 'total opioid used, measure in morphine equivalents', 'unitOfMeasure': 'morphine milligram equivalents', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antiemetic Use POD 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours postoperatively', 'description': 'total antiemetic used', 'unitOfMeasure': 'antiemetic doses', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antiemetic Use 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week postoperatively', 'description': 'total antiemetic used', 'unitOfMeasure': 'antiemetic doses', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours postoperatively', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week postoperatively', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'FG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Data collection occurred from 1/5/2021 to 1/21/2021'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.\n\nLiposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.'}, {'id': 'BG001', 'title': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.\n\nStandard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '54'}, {'value': '35', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '35'}, {'value': '45.1', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '54'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'BG000'}, {'value': '19.1', 'groupId': 'BG001'}, {'value': '22.5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'kilograms per meter squared'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-09', 'size': 285110, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-30T16:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'division wide research suspension', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2019-12-23', 'resultsFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-16', 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Use at 24 Hours', 'timeFrame': '24 hours postoperatively', 'description': 'Amount of opioids used postoperatively, measured in morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Quality of Recovery-40 (QOR-40) Score', 'timeFrame': '24 hours postoperatively', 'description': 'The QOR-40 is a 40 item survey about the quality of recovery with a total possible range of scores from 40 to 200 where the higher the score the higher quality the recovery.'}, {'measure': 'Pain Score Postoperative Day 1 (POD 1)', 'timeFrame': '24 hours postoperatively', 'description': 'The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.'}, {'measure': 'Pain Score 1 Week Postop', 'timeFrame': '1 week postoperatively', 'description': 'The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.'}, {'measure': 'Opioid Use at 1 Week', 'timeFrame': '1 week postoperatively', 'description': 'total opioid used, measure in morphine equivalents'}, {'measure': 'Antiemetic Use POD 1', 'timeFrame': '24 hours postoperatively', 'description': 'total antiemetic used'}, {'measure': 'Antiemetic Use 1 Week', 'timeFrame': '1 week postoperatively', 'description': 'total antiemetic used'}, {'measure': 'Number of Participants With Postoperative Nausea and Vomiting', 'timeFrame': '24 hours postoperatively'}, {'measure': 'Number of Participants With Postoperative Complications', 'timeFrame': '1 week postoperatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominoplasty', 'enhanced recovery after surgery', 'Liposomal bupivacaine'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of postoperative nausea and vomiting (PONV), and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in 46 participants 18 years and older undergoing elective abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.', 'detailedDescription': 'Postoperative pain, nausea, and vomiting can be frustrating sequelae of elective surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. Despite the use of multiple techniques for managing postoperative pain in abdominoplasty patients, pain control continues to be a challenge for this patient population.\n\nOne technique commonly employed to improve pain control is the use of abdominal wall and incisional injection of local anesthetic agents to block the sensory nerves supplying the anterior abdominal wall and abdominal incisions in order to decrease sensation and pain in the abdomen in the setting of abdominoplasty surgery. Local anesthetic often used in this procedure is bupivacaine (Marcaine) ± epinephrine. However, in 2012, a liposomal bupivacaine suspension (Exparel; Pacira BioSciences, Inc, San Diego, California) was introduced as a longer-acting local anesthetic used for management of postoperative pain. At the University of Wisconsin, patients undergoing abdominoplasty routinely receive intraoperative injection of local anesthetic to the abdominal wall and abdominal incisions, using bupivacaine as the local anesthetic, along with standard multimodal perioperative pain management including cool compresses, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids.\n\nThe overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of PONV, and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in patients undergoing abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC).\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Incarcerated women or men\n* Individuals unable to give consent due to another condition such as impaired decision-making capacity.\n* Men or women who take opioid pain medications on a regular basis prior to surgery\n* Men or women with a history of opioid abuse and/or dependence\n* Participants with a history of bleeding disorders precluding safe abdominoplasty\n* Participants on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist\n* Participants not medically cleared for surgery at Madison Surgery Center. This would include participants with sepsis/bacteremia, significant valvular disorders or heart conditions.'}, 'identificationModule': {'nctId': 'NCT04254692', 'briefTitle': 'Optimizing Recovery in Abdominoplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty', 'orgStudyIdInfo': {'id': '2019-1570'}, 'secondaryIdInfos': [{'id': 'A539730', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/SURGERY/DENTL-PLASTC SRGY', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Ver 2, 04/09/2021', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.', 'interventionNames': ['Drug: Liposomal bupivacaine']}, {'type': 'OTHER', 'label': 'Bupivacaine', 'description': 'Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Liposomal bupivacaine', 'type': 'DRUG', 'description': 'Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.', 'armGroupLabels': ['Liposomal Bupivacaine']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall', 'armGroupLabels': ['Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Madison Surgery Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Venkat Rao, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin Hospitals and Clinics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}