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Narcotic vs. Non-Narcotic Pain Study Protocol

April 5, 2019

Overview

This study has two purposes: 1. To determine whether the most commonly used non-narcotic analgesic medication (ibuprofen 600mg + acetaminophen 325mg) provides pain relief that is not worse than the relief provided by a narcotic analgesic medication (hydrocodone 5mg + acetaminophen 325mg) in patients undergoing carpal tunnel release; and 2. To determine whether gender, country, pre-operative CTS symptoms, site, workers compensation status, and employment status affects pain level following surgery or medication usage. Participants will be be instructed to fill out pain intensity scores, pain interference scores, a pain medication diary, and a final pain relief assessment.

 

Study Information

This is an interventional, randomized, quadruple blind (Participant, Care Provider, Investigator, Outcomes Assessor) parallel assignment with an estimated 400 participants. It consists of an experimental arm (narcotic of hydrocodone + acetaminophen, 4 times per day, 1 week after surgery) and an active comparator arm (non-narcotic of ibuprofen + acetaminophen, 4 times per day, 1 week after surgery).

 

Inclusion Criteria

All patients undergoing primary carpal tunnel release are eligible to participate.

Exclusion Criteria

  • Individuals who previously enrolled in this study (for carpal tunnel surgery on the other hand)
  • Have a history of chronic opioid use or suspected substance abuse
  • Individuals currently on daily use of ibuprofen, acetaminophen or other pain altering medication (including medications like gabapentin and tramadol)
  • Those with a reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen
  • Have 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 (or history of severe heartburn)
  • Those with symptoms of infection
  • Pregnant or lactating women
  • Those with a diagnosis of cognitive impairment
  • Patients unable or unwilling to provide informed consent for surgery or clinical trial enrollment
  • Unable or unwilling to fill out forms
  • Had prior carpal tunnel surgery on the hand to be operated on
  • Individuals currently taking Coumadin, Plavix, or medications that increase bleeding
  • Patients with other medical or psychological health conditions that preclude them from receiving either intervention or returning for follow-up visits

Location

Locations for this study who are still recruiting include Sanford Orthopedics and Sports Medicine in Sioux Falls, South Dakota, Carilion Clinic in Roanoke Virginia, Horizon Health Network in Saint John, New Brunswick, Canada, the Lawson Health Research Institute in London, Ontario, Canada, and the University of Western Ontario, Canada in Ontario, Canada.

Sponsors/Collaborators

Sponsors and collaborators of this study include: Horizon Health Network, Lawson Health Research Institute, the University of Michigan, Jefferson Medical College of Thomas Jefferson University, McGill University, the University of Western Ontario, Canada, Sanford Health, and Carilion Clinic. The Principal Investigator is Donald Lalonde, MD of Saint John, NB.

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