Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT05556356
Status:
TERMINATED
Last Update Posted:
2024-10-08
First Post:
2022-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants unblinded following final data collection.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Physician decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '2 weeks', 'description': 'Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)'}, {'measure': 'Number of Narcotic Pills Used', 'timeFrame': '2 weeks', 'description': 'Number of Narcotic Pills Used'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpometacarpal Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years of age or older)\n* Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis\n* Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays\n* Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study\n* Bilateral thumbs included\n\nExclusion Criteria:\n\n* \\<18 years age\n* Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints\n* Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy\n* History of opioid dependency or current chronic opioid use\n* Contraindication to acetaminophen use\n* Contraindication to NSAID use\n* Contraindication or known allergy to peripheral nerve blockade, including coagulopathy\n* Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade.\n* Contraindication to multivitamin use\n* Liver dysfunction'}, 'identificationModule': {'nctId': 'NCT05556356', 'briefTitle': 'Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Indiana Hand to Shoulder Center'}, 'officialTitle': 'Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis', 'orgStudyIdInfo': {'id': 'IU15386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Preoperative multivitamin and postoperative standardized pain management regimen', 'interventionNames': ['Other: Placebo: Multivitamin']}, {'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': ': Preoperative acetaminophen and postoperative standardized pain management regimen', 'interventionNames': ['Drug: Acetaminophen']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'pre-operative acetaminophen (1000mg)', 'armGroupLabels': ['Test Group']}, {'name': 'Placebo: Multivitamin', 'type': 'OTHER', 'description': 'pre-operative Multivitamin', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hand to Shoulder Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana Hand to Shoulder Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}