Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing trapeziectomy for thumb osteoarthritis
Disqualifiers
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
NSAID capsules
Drug1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage
Opioid capsule
Drug1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage
Treatment groups
121 Participants
are divided into 2 treatment groupsGroup A: NSAIDSExperimental treatment 1 intervention
Group B: OpioidsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Every day from the first day after surgery to 30 days post-op.2
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.3
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.4
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.Secondary outcomes
1
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 82
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 8Sponsors and contacts
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Source ClinicalTrials.gov