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Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Primary Purpose

Pain, Postoperative, Osteoarthritis Thumb

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NSAID capsules
Opioid capsule
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NSAIDS

Opioids

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
December 16, 2020
Last Updated
January 31, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04676802
Brief Title
Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
Official Title
Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2021 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Osteoarthritis Thumb

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSAIDS
Arm Type
Experimental
Arm Description
Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.
Arm Title
Opioids
Arm Type
Experimental
Arm Description
Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.
Intervention Type
Drug
Intervention Name(s)
NSAID capsules
Intervention Description
1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage
Intervention Type
Drug
Intervention Name(s)
Opioid capsule
Intervention Description
1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage
Primary Outcome Measure Information:
Title
Change of medication consumption and overall amount
Description
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.
Time Frame
Every day from the first day after surgery to 30 days post-op.
Title
Change of worst daily pain score measured over time
Description
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.
Time Frame
Every day from the first day after surgery to 30 days post-op.
Title
Change of least daily pain score measured over time
Description
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.
Time Frame
Every day from the first day after surgery to 30 days post-op.
Title
Change of average daily pain score measured over time
Description
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.
Time Frame
Every day from the first day after surgery to 30 days post-op.
Secondary Outcome Measure Information:
Title
Change in Quick DASH scores over time
Description
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.
Time Frame
Baseline, Post-operative weeks 1, 3, 5, and 8
Title
Change in PROMIS-PI scores over time
Description
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).
Time Frame
Baseline, Post-operative weeks 1, 3, 5, and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Kenney, MS OTR
Phone
6507217644
Email
dkenney@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Ladd, MD
Organizational Affiliation
Stanford Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Kenney, MS OTR
Phone
650-721-7644
Email
dkenney@stanford.edu
First Name & Middle Initial & Last Name & Degree
Amy Ladd, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

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