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Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

NCT04676802 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-08-06

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Amy Ladd, MD · Stanford Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2027-02-28
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676802 on ClinicalTrials.gov