Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Study Overview
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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.

Official Title
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Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone

Conditions
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Pain, Postoperative, Osteoarthritis Thumb

Intervention / Treatment
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* Drug: NSAID capsules
* Drug: Opioid capsule


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSAIDS<br>Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys. | Drug: NSAID capsules<br>* 1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage<br>|
| Experimental: Opioids<br>Following surgery will receive opioid capsules following surgery. Will take online and phone surveys. | Drug: Opioid capsule<br>* 1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of medication consumption and overall amount | 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. | Every day from the first day after surgery to 30 days post-op. | 
| Change of worst daily pain score measured over time | 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. | Every day from the first day after surgery to 30 days post-op. | 
| Change of least daily pain score measured over time | 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. | Every day from the first day after surgery to 30 days post-op. | 
| Change of average daily pain score measured over time | 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. | Every day from the first day after surgery to 30 days post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quick DASH scores over time | 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. | Baseline, Post-operative weeks 1, 3, 5, and 8 | 
| Change in PROMIS-PI scores over time | 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. We 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). | Baseline, Post-operative weeks 1, 3, 5, and 8 |