Actively Recruiting
Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone
Led by Stanford University · Updated on 2025-08-06
121
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pain management options after trapeziectomy surgery for osteoarthritis at the base of the thumb. This phase 2 clinical trial compares the effectiveness of non-narcotic medications—specifically a combination of ibuprofen and acetaminophen—to an opioid medication, oxycodone, for controlling pain in the first 30 days after surgery. The goal is to find a way to reduce opioid use while still managing pain effectively during recovery. Participants will be randomly assigned to one of two groups: one group will receive NSAID capsules containing ibuprofen and acetaminophen, and the other group will receive opioid capsules containing oxycodone and a placebo. Both groups will follow their assigned medication regimen after surgery and will complete online and phone surveys to report their experiences. This study involves careful monitoring of medication use and pain levels daily for 30 days post-operation. During the study, participants will report their worst, least, and average daily pain scores, along with their medication consumption each day for 30 days after surgery. Additional assessments include measuring arm and hand function using Quick DASH scores and pain interference using PROMIS-PI scores at baseline and several postoperative weeks. The study uses a randomized, quadruple-masked design to ensure reliable results and includes safety monitoring throughout the participation period.
CONDITIONS
Brief Title
Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing trapeziectomy for thumb osteoarthritis
- Able to read and understand English
You will not qualify if you...
- Pregnancy
- Current use of opioids
- Having concurrent surgeries such as trapeziectomy combined with carpal tunnel release
- Inability to complete study forms due to education, cognitive ability, mental or medical status
- Allergy or intolerance to ibuprofen, acetaminophen, or oxycodone
- Liver or kidney dysfunction or 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo trapeziectomy surgery followed by immediate post-operative care while starting assigned pain relief medication.
1 surgery day visit (in-person)
Duration - 30 days
Participants take assigned medication (NSAID capsules or opioid capsules) and complete daily pain and medication consumption surveys.
Daily online or phone surveys for 30 days
Duration - 8 weeks
Participants complete follow-up assessments of arm function and pain interference at baseline and post-operative weeks 1, 3, 5, and 8.
5 visits including baseline and post-operative weeks 1, 3, 5, and 8
Trial Site Locations
Total: 2 locations
1
Stanford Health Care
Redwood City, California, United States, 94063
Actively Recruiting
2
University of Utah Health Care
Salt Lake City, Utah, United States, 84112-
Actively Recruiting
Research Team
D
Deborah Kenney, MS OTR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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