Recruiting
Phase 2

Ibuprofen & Oxycodone

Sponsor:

Stanford University

Code:

NCT04676802

Conditions

Pain, Postoperative

Osteoarthritis Thumb

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

NSAID capsules

Opioid capsule

Study Details

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.

Conditions

Pain, Postoperative

Osteoarthritis Thumb

Study ID

NCT04676802

Start date

Dec 27, 2021

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

121 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NSAIDS

Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.

experimental: Opioids

Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.

Interventions

NSAID capsules

1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage

Opioid capsule

1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Deborah Kenney, MS OTR

6507217644dkenney@stanford.edu

Locations

Stanford Health Care

Recruiting

Redwood City, California, United States, 94063

Contacts

Deborah Kenney, MS OTR

(650) 721-7644dkenney@stanford.edu

Principal Investigator:

Amy Ladd, MD

University of Utah Health Care

Recruiting

Salt Lake City, Utah, United States, 84112-

Contacts

Mario Quesada, PS

u6051225@utah.edu

Principal Investigator:

Angela Wang, MD

More Information

Sponsor

Stanford University

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-11.