NCT04676802 Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
| NCT ID | NCT04676802 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 121 participants |
| Start Date | 2021-12-27 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 121 participants in total. It began in 2021-12-27 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Amy Ladd, MD
PRINCIPAL INVESTIGATOR
Stanford Orthopaedic Surgery
Frequently Asked Questions
Who can join the NCT04676802 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04676802 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04676802 currently recruiting?
Yes, NCT04676802 is actively recruiting participants. Contact the research team at dkenney@stanford.edu for enrollment information.
Where is the NCT04676802 trial being conducted?
This trial is being conducted at Redwood City, United States, Salt Lake City, United States.
Who is sponsoring the NCT04676802 clinical trial?
NCT04676802 is sponsored by Stanford University. The principal investigator is Amy Ladd, MD at Stanford Orthopaedic Surgery. The trial plans to enroll 121 participants.