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NCT Number: NCT04676802

Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Osteoarthritis Thumb Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Health Care, Redwood City, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NSAID capsules

Drug

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

Opioid capsule

Drug

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

Primary outcomes

  1. Change of medication consumption and overall amount

    Time frame: Every day from the first day after surgery to 30 days post-op.

    The number of capsules consumed in the last 24 hours. Consumption rate and overall consumption will be compared between groups to assess efficacy and inform further statistical analyses.

  2. Change of worst daily pain score measured over time

    Time frame: Every day from the first day after surgery to 30 days post-op.

    Numerical score describing surgical pain at its worst in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.

  3. Change of least daily pain score measured over time

    Time frame: Every day from the first day after surgery to 30 days post-op.

    Numerical score describing surgical pain at its least in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.

  4. Change of average daily pain score measured over time

    Time frame: Every day from the first day after surgery to 30 days post-op.

    Numerical score describing average surgical pain in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.

Secondary outcomes

  1. Change in Quick DASH scores over time

    Time frame: Baseline, Post-operative weeks 1, 3, 5, and 8

    Quick Disabilities of the Arm, Shoulder, and Hand (qDASH) is a responsive measure to patient-reported functional change in the hand and upper extremity patient population, ranging from 0 to 100. Lower scores signify limited function and increased pain.

  2. Change in PROMIS-PI scores over time

    Time frame: Baseline, Post-operative weeks 1, 3, 5, and 8

    PROMIS-PI scores (Patient-Reported Outcomes Measurement Information System - Pain Interference) are effective measures of the change in perceived pain, supporting intervention related studies assessing power analyses for comparative research.

    We use the Pain Interference - Short Form version 6b, which consists of 6 questions regarding how much the pain experienced in the last 7 days interfered with everyday aspects of life (i.e. enjoyment, ability to concentrate, day to day activities, recreational activities, doing tasks away from home, and socializing with others). The answers to all questions are ordinals ranging from 1 (not interfered at all) to 5 (interfered very much).

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Kenney, MS OTR

CONTACT

[email protected]

6507217644

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2020
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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