CompletedPhase 4

Narcotic vs. Non-narcotic Pain Study Protocol

United States, Canada347 participantsStarted 2016-03

Plain-language 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)

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients undergoing elective a primary carpal tunnel release will be considered eligible Exclusion Criteria: * 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 f…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain relief

Timeframe: 7-15 days

Trial details

NCT IDNCT01974609

SponsorHorizon Health Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-24

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