Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04676802
• Other study ID #: 58972
• Status: Recruiting
• Phase: Phase 2
• Start date: December 27, 2021
• Est. completion date: August 2026

Study information

• Verified date: January 2023
• Source: Stanford University
• Contact: Deborah Kenney, MS OTR
• Phone: 6507217644
• Email: dkenney[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 121
• Est. completion date: August 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis Thumb
• Pain, Postoperative

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Stanford Health Care	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Change in Quick DASH scores over time	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.	Baseline, Post-operative weeks 1, 3, 5, and 8
Secondary	Change in PROMIS-PI scores over time	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).	Baseline, Post-operative weeks 1, 3, 5, and 8