Narcotic vs. Non-narcotic Pain Study Protocol

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Health Network
• Collaborators: Carilion Clinic; Jefferson Medical College of Thomas Jefferson University; Lawson Health Research Institute; McGill University; Sanford Health; Southern Illinois University; University of Michigan; University of Toronto; University of Western Ontario, Canada
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Ibuprofen; Narcotics

Criteria

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 from receiving either intervention or returning for follow-up visits