Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04676802
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2020-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}], 'ancestors': [{'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 121}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of medication consumption and overall amount', 'timeFrame': 'Every day from the first day after surgery to 30 days post-op.', 'description': 'The number of capsules consumed in the last 24 hours. Consumption rate and overall consumption will be compared between groups to assess efficacy and inform further statistical analyses.'}, {'measure': 'Change of worst daily pain score measured over time', 'timeFrame': 'Every day from the first day after surgery to 30 days post-op.', 'description': 'Numerical score describing surgical pain at its worst in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.'}, {'measure': 'Change of least daily pain score measured over time', 'timeFrame': 'Every day from the first day after surgery to 30 days post-op.', 'description': 'Numerical score describing surgical pain at its least in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.'}, {'measure': 'Change of average daily pain score measured over time', 'timeFrame': 'Every day from the first day after surgery to 30 days post-op.', 'description': 'Numerical score describing average surgical pain in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Quick DASH scores over time', 'timeFrame': 'Baseline, Post-operative weeks 1, 3, 5, and 8', 'description': 'Quick Disabilities of the Arm, Shoulder, and Hand (qDASH) is a responsive measure to patient-reported functional change in the hand and upper extremity patient population, ranging from 0 to 100. Lower scores signify limited function and increased pain.'}, {'measure': 'Change in PROMIS-PI scores over time', 'timeFrame': 'Baseline, Post-operative weeks 1, 3, 5, and 8', 'description': 'PROMIS-PI scores (Patient-Reported Outcomes Measurement Information System - Pain Interference) are effective measures of the change in perceived pain, supporting intervention related studies assessing power analyses for comparative research.\n\nWe use the Pain Interference - Short Form version 6b, which consists of 6 questions regarding how much the pain experienced in the last 7 days interfered with everyday aspects of life (i.e. enjoyment, ability to concentrate, day to day activities, recreational activities, doing tasks away from home, and socializing with others). The answers to all questions are ordinals ranging from 1 (not interfered at all) to 5 (interfered very much).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Osteoarthritis Thumb']}, 'descriptionModule': {'briefSummary': 'In the US, pain management after surgery for surgical treatment of osteoarthritis at the base of the thumb typically consists of prescription opioids during the early recovery phase. Given the highly addictive nature of prescription opioids, guidelines are being evaluated by hand surgeons to reduce opioid use while still maintaining pain control after surgery. A promising approach is to use non-narcotic medication as the first line of treatment. The purpose of this study is to demonstrate the efficacy of a combination of non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen, in comparison to a morphine analogue substance (oxycodone) for pain management in the first 30 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing trapeziectomy for thumb osteoarthritis\n\nEnglish proficient,\n\nExclusion Criteria:\n\n* Pregnancy\n\nCurrent use of opioids\n\nConcurrent surgeries (ex. trapeziectomy combined with carpal tunnel release)\n\nInability to complete study forms (education, cognitive ability, mental status, medical status)\n\nAllergy or intolerance to Ibuprofen, Acetaminophen and/or Oxycodone\n\nLiver or kidney dysfunction, abnormal liver enzymes restricting use of acetaminophen or ibuprofen\n\nHistory of chronic heart failure, upper gastrointestinal bleeding or coagulopathy\n\nHistory of complex regional pain syndrome'}, 'identificationModule': {'nctId': 'NCT04676802', 'briefTitle': 'Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone', 'orgStudyIdInfo': {'id': '58972'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NSAIDS', 'description': 'Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.', 'interventionNames': ['Drug: NSAID capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Opioids', 'description': 'Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.', 'interventionNames': ['Drug: Opioid capsule']}], 'interventions': [{'name': 'NSAID capsules', 'type': 'DRUG', 'description': '1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage', 'armGroupLabels': ['NSAIDS']}, {'name': 'Opioid capsule', 'type': 'DRUG', 'description': '1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage', 'armGroupLabels': ['Opioids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deborah Kenney, MS OTR', 'role': 'CONTACT', 'email': 'dkenney@stanford.edu', 'phone': '(650) 721-7644'}, {'name': 'Amy Ladd, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '84112-', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mario Quesada, PS', 'role': 'CONTACT', 'email': 'u6051225@utah.edu'}, {'name': 'Angela Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah Health Care', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Deborah Kenney, MS OTR', 'role': 'CONTACT', 'email': 'dkenney@stanford.edu', 'phone': '6507217644'}], 'overallOfficials': [{'name': 'Amy Ladd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Orthopaedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopaedic Surgery', 'investigatorFullName': 'Amy Ladd', 'investigatorAffiliation': 'Stanford University'}}}}