Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-23 @ 9:21 AM
Study NCT ID:
NCT03817034
Status:
WITHDRAWN
Last Update Posted:
2021-04-01
First Post:
2018-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'We decided to close this study and come up with a new study design.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-28', 'studyFirstSubmitDate': '2018-11-23', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in post-operative opioid consumption', 'timeFrame': '48 hours', 'description': 'Decreased post-operative opioid consumption associated with use of multimodal analgesia'}, {'measure': 'Change in post-operative pain scores', 'timeFrame': '48 hours', 'description': 'Decreased post-operative pain scores associated with use of multimodal analgesia'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multimodal', 'dexmedetomidine', 'ropivacaine', 'ketorolac', 'pain management', 'opioid sparing', 'analgesia'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The investigators are performing this research study to investigate the efficacy of local infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac (treatment group) versus the current standard of care (historical control group), for post-operative pain management.', 'detailedDescription': 'During this research study, patients recommended for a rectus sheath block during surgery will receive a novel combination of non-opioid drugs. Data from the treatment group will be compared to surgical outcomes of a historically matched control group to investigate the ability of this drug combination to reduce post-operative pain and post-operative opioid consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years\n* American Society of Anesthesiologist Physical Status Classification 1-3\n* Undergoing surgery requiring a rectus sheath block\n\nExclusion Criteria:\n\n* American Society of Anesthesiologist Physical Status Classification of 4 or beyond\n* history of opiate of illicit substance abuse, chronic pain, or neurological dysfunction'}, 'identificationModule': {'nctId': 'NCT03817034', 'briefTitle': 'Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption', 'orgStudyIdInfo': {'id': '2018P002053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal Analgesia', 'interventionNames': ['Drug: Multimodal analgesia']}], 'interventions': [{'name': 'Multimodal analgesia', 'type': 'DRUG', 'description': 'Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac', 'armGroupLabels': ['Multimodal Analgesia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Emery N Brown, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Neuroscience Statistics Research Laboratory', 'investigatorFullName': 'Emery Brown', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}