Carpal Tunnel | Narcotic vs. Non-narcotic Pain Study Protocol
Carpal Tunnel research study
What is the primary objective of this study?
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 is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:NarcoticHydrocodone 5mg + acetaminophen 325 mg
Drug:non-narcoticibuprofen 600mg + acetaminophen 325 mg
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
NarcoticHydrocodone + acetaminophen 4 times per day 1 week after surgery
non-narcoticibuprofen + acetaminophen 4 times per day 1 week after surgery
Start Date: March 2016
Completed Date: March 2019
Phase: Phase 4
Primary Outcome: Pain relief
Study sponsors, principal investigator, and references
Principal Investigator: Donald Lalonde, MD
Lead Sponsor: Horizon Health Network
Collaborator: Lawson Health Research Institute