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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage
1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage
Stanford Health Care
Redwood City, California, United States
RECRUITINGUniversity of Utah Health Care
Salt Lake City, Utah, United States
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Every day from the first day after surgery to 30 days post-op.
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.
Time frame: 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).
Time frame: Baseline, Post-operative weeks 1, 3, 5, and 8
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