Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-27

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative Osteoarthritis Thumb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NSAIDS

Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.

Group Type EXPERIMENTAL

NSAID capsules

Intervention Type DRUG

1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage

Opioids

Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.

Group Type EXPERIMENTAL

Opioid capsule

Intervention Type DRUG

1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage

Interventions

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NSAID capsules

1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage

Intervention Type DRUG

Opioid capsule

1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undergoing trapeziectomy for thumb osteoarthritis

English proficient,

Exclusion Criteria

* Pregnancy

Current use of opioids

Concurrent surgeries (ex. trapeziectomy combined with carpal tunnel release)

Inability to complete study forms (education, cognitive ability, mental status, medical status)

Allergy or intolerance to Ibuprofen, Acetaminophen and/or Oxycodone

Liver or kidney dysfunction, abnormal liver enzymes restricting use of acetaminophen or ibuprofen

History of chronic heart failure, upper gastrointestinal bleeding or coagulopathy

History of complex regional pain syndrome

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No