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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04676802
Other study ID # 58972
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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