Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis

Phase 4

Terminated

• Conditions: Carpometacarpal Osteoarthritis
• Interventions: Drug: Acetaminophen

• Registration Number: NCT05556356
• Lead Sponsor: Indiana Hand to Shoulder Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-13
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Primary Completion: 2024-05-06
• Study Completion: 2024-05-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Adults (18 years of age or older)
• Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
• Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
• Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
• Bilateral thumbs included

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Exclusion Criteria

• <18 years age
• Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints
• Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
• History of opioid dependency or current chronic opioid use
• Contraindication to acetaminophen use
• Contraindication to NSAID use
• Contraindication or known allergy to peripheral nerve blockade, including coagulopathy
• Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade.
• Contraindication to multivitamin use
• Liver dysfunction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Acetaminophen	: Preoperative acetaminophen and postoperative standardized pain management regimen

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	2 weeks	Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)
Number of Narcotic Pills Used	2 weeks	Number of Narcotic Pills Used

Trial Locations

Locations (1)

Indiana Hand to Shoulder Center; 🇺🇸 Indianapolis, Indiana, United States