Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-04 @ 7:37 AM
Study NCT ID:
NCT03455751
Status:
TERMINATED
Last Update Posted:
2019-03-18
First Post:
2018-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Failed to meet enrollment goals', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2018-02-28', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative opioid use', 'timeFrame': 'Post-op day 1', 'description': 'Post-operative opioid use through visual analog scale guided administration of narcotic equivalent'}, {'measure': 'Overall Benefit of Analgesia Score (OBAS)', 'timeFrame': 'Post-op day 1'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': '30 days'}, {'measure': 'Readmission rate', 'timeFrame': '30 days'}, {'measure': 'Functional status', 'timeFrame': '4 weeks and 3 months', 'description': 'Assessed through Duke Activity Status Index (DASI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain Management', 'Pharmacogenomics'], 'conditions': ['Colorectal Cancer', 'Diverticular Disease', 'Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject capable of giving consent\n* Age 18-80\n* Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)\n\nExclusion Criteria:\n\n* Patient does not speak English\n* Patient with substance-use disorder (including alcohol)\n* Patient diagnosed with major depression\n* Patient currently taking opioids\n* Previous long-term opioid use (\\> 3 months)\n* Previous opioid use with a dose of \\>100 milligram morphine equivalent (MME)\n* Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)\n* Documented allergy to pain medication'}, 'identificationModule': {'nctId': 'NCT03455751', 'acronym': 'PPaM', 'briefTitle': 'Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery', 'orgStudyIdInfo': {'id': '17-1540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control arm will receive no intervention and will follow standard of care for post-operative pain management.'}, {'type': 'EXPERIMENTAL', 'label': 'PGx-guided', 'description': 'The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.', 'interventionNames': ['Genetic: PGx-guided post-operative pain management']}], 'interventions': [{'name': 'PGx-guided post-operative pain management', 'type': 'GENETIC', 'description': 'Post-operative pain management as indicated by pharmacogenomic testing results.', 'armGroupLabels': ['PGx-guided']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'David Liska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Staff, Colorectal Surgery', 'investigatorFullName': 'David Liska', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}