Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Pain Relief After Trapeziectomy Without Opioids: 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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Osteoarthritis Thumb
• Intervention / Treatment: Drug: NSAID capsules; Drug: Opioid capsule

• Study Type: Interventional
• Enrollment (Anticipated): 121
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Deborah Kenney, MS OTR; Phone Number: 6507217644; Email: dkenney@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford Health Care
      • Contact: Deborah Kenney, MS OTR; Phone Number: 650-721-7644; Email: dkenney@stanford.edu
      • Principal Investigator: Amy Ladd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NSAIDS; Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.	Drug: NSAID capsules; 1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage
Experimental: Opioids; Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.	Drug: Opioid capsule; 1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Amy Ladd, MD, Stanford Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2021
• Primary Completion (Anticipated): February 1, 2026
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 58972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No