Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

NCT04676802 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 58972
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Change of medication consumption and overall amount

  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.

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

• Change of worst daily pain score measured over time

  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.

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

• Change of least daily pain score measured over time

  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.

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

• Change of average daily pain score measured over time

  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.

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

Secondary Outcomes (2)

• Change in Quick DASH scores over time

  Baseline, Post-operative weeks 1, 3, 5, and 8

• Change in PROMIS-PI scores over time

  Baseline, Post-operative weeks 1, 3, 5, and 8

Study Arms (2)

NSAIDS

EXPERIMENTAL

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

Drug: NSAID capsules

Opioids

EXPERIMENTAL

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

Drug: Opioid capsule

Interventions

NSAID capsules DRUG

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

NSAIDS

Opioid capsule DRUG

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

Opioids

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing trapeziectomy for thumb osteoarthritis
• English proficient,

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford Health Care

Redwood City, California, 94063, United States

RECRUITING

University of Utah Health Care

Salt Lake City, Utah, 84112-, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Opioid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Narcotics; Central Nervous System Depressants; Central Nervous System Agents

Study Officials

• Amy Ladd, MD

  Stanford Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Kenney, MS OTR

CONTACT

6507217644; dkenney@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: December 27, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)