Narcotic vs. Non-narcotic Pain Study Protocol
A Randomized, Controlled Trial Comparing Combination Therapy of Ibuprofen + Acetaminophen Versus Hydrocodone + Acetaminophen for the Treatment of Pain After Carpal Tunnel Surgery
1 other identifier
interventional
347
2 countries
7
Brief Summary
The purposes of this noninferiority randomized clinical trial are to:
- 1.determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg. + acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal tunnel release.
- 2.Determine whether the following covariates affect pain level following surgery or medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site, workers compensation status and employment status (employed/self-employed/unemployed-able to work/unemployed-unable to work)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2016
Longer than P75 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2022
CompletedMarch 11, 2022
February 1, 2022
6 years
October 28, 2013
February 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain relief
1\. Determine whether the most commonly used nonnarcotic analgesics (ibuprofen 600 mg + acetaminophen 325 mg) provide pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg + acetaminophen 325 mg, equivalent to Norco® 5/325) in patients undergoing carpal tunnel release.
7-15 days
Study Arms (2)
Narcotic
EXPERIMENTALHydrocodone + acetaminophen 4 times per day 1 week after surgery
non-narcotic
ACTIVE COMPARATORibuprofen + acetaminophen 4 times per day 1 week after surgery
Interventions
ibuprofen 600mg + acetaminophen 325 mg
Eligibility Criteria
You may qualify if:
- All patients undergoing elective a primary carpal tunnel release will be considered eligible
You may not qualify if:
- Patients wil be excluded for any of the following:
- previously enrolled in this study (for carpal tunnel surgery on the other hand);
- history of chronic opioid use;
- documented or suspected substance abuse;
- individuals currently on daily use of ibuprofen, acetaminophen or other pain altering medication including medications like Neurontin (gabapentin) and Ultram (tramadol)
- individuals with documented or suspected chronic pain syndrome;
- reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen;
- those with a history or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease);
- patients with active peptic ulcer disease (history of severe heartburn);
- symptoms of infection with initial enrollment;
- pregnant or lactating women;
- those with a diagnosis of cognitive impairment;
- patients unable or unwilling to provide informed consent for surgery or enrollment in a clinical trial;
- patients unable or unwilling to fill out the forms or understand the consent form
- prior carpal tunnel surgery on the hand to be operated on
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Horizon Health Networklead
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'scollaborator
- University of Michigancollaborator
- Jefferson Medical College of Thomas Jefferson Universitycollaborator
- McGill Universitycollaborator
- University of Western Ontario, Canadacollaborator
- Sanford Healthcollaborator
- Carilion Cliniccollaborator
Study Sites (7)
The Philadelphia Hand Center
Philadelphia, Pennsylvania, 19107, United States
Sanford orthopedics and Sports Medicine-Sioux Falls
Sioux Falls, South Dakota, 57104, United States
CarilionClinic
Roanoke, Virginia, 24014, United States
Horizon Health Network
Saint John, New Brunswick, E2L 4L4, Canada
Lawson Health Research Institute
London, Ontario, N6A 4V2, Canada
University of Western Ontario, Canada
London, Ontario, Canada
McGill University
Montreal, Quebec, H3A 0G4, Canada
Related Publications (1)
Lalonde DH, Lalonde JF, MacDermid JC, Chung KC, Gan BS, Mierisch C, Van Demark RE Jr, Luc M. Time to Stop Routinely Prescribing Opiates after Carpal Tunnel Release. Plast Reconstr Surg. 2022 Mar 1;149(3):651-660. doi: 10.1097/PRS.0000000000008834.
PMID: 35041636BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Lalonde, MD
Saint John, NB
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 1, 2013
Study Start
March 1, 2016
Primary Completion
February 24, 2022
Study Completion
February 24, 2022
Last Updated
March 11, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share