Narcotic vs. Non-narcotic Pain Study Protocol
Completed · Phase 4
Conditions studied: Carpal Tunnel
In brief
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)
Key facts
- Study ID
- NCT01974609
- Run by
- Horizon Health Network
- People needed
- 347
- Starts
- 2016-03-01
- Expected to finish
- 2022-02-24
- Last updated by the study team
- 2022-03-11
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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
- individuals currently taking Coumadin, Plavix, or medications that increase bleeding; or
- patients with other medical or psychological health conditions that preclude then from receiving either intervention or returning for follow-up visits
Where it is running
- The Philadelphia Hand Center — Philadelphia, Pennsylvania, United States
- Sanford orthopedics and Sports Medicine-Sioux Falls — Sioux Falls, South Dakota, United States
- CarilionClinic — Roanoke, Virginia, United States
- Horizon Health Network — Saint John, New Brunswick, Canada
- Lawson Health Research Institute — London, Ontario, Canada
- University of Western Ontario, Canada — London, Ontario, Canada
- McGill University — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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