NCT04676802

Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Osteoarthritis Thumb

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-27
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2020-12-21
• Last updated: 2025-08-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study