Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone (NCT04676802) | Clinical Trial Compass
RecruitingPhase 2
Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
United States121 participantsStarted 2021-12-27
Plain-language summary
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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of medication consumption and overall amount
Timeframe: Every day from the first day after surgery to 30 days post-op.
2
Change of worst daily pain score measured over time
Timeframe: Every day from the first day after surgery to 30 days post-op.
3
Change of least daily pain score measured over time
Timeframe: Every day from the first day after surgery to 30 days post-op.
4
Change of average daily pain score measured over time
Timeframe: Every day from the first day after surgery to 30 days post-op.