Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NSAID capsules, Opioid capsule.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Osteoarthritis Thumb. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone
Overview
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.
Interventions
- Drug NSAID capsules
1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage - Drug Opioid capsule
1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage
Primary outcome measures
- Change of medication consumption and overall amount [Time frame: Every day from the first day after surgery to 30 days post-op.]
- Change of worst daily pain score measured over time [Time frame: Every day from the first day after surgery to 30 days post-op.]
- Change of least daily pain score measured over time [Time frame: Every day from the first day after surgery to 30 days post-op.]
- Change of average daily pain score measured over time [Time frame: Every day from the first day after surgery to 30 days post-op.]
Secondary outcome measures (2)
- Change in Quick DASH scores over time [Time frame: Baseline, Post-operative weeks 1, 3, 5, and 8]
- Change in PROMIS-PI scores over time [Time frame: Baseline, Post-operative weeks 1, 3, 5, and 8]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Stanford Health Care — Redwood City
- University of Utah Health Care — Salt Lake City
Identifiers
NCT: NCT04676802 · 58972