Clinical trial NCT01974609: Narcotic vs. Non-narcotic Pain Study Protocol
Official title: A Randomized, Controlled Trial Comparing Combination Therapy of Ibuprofen + Acetaminophen Versus Hydrocodone + Acetaminophen for the Treatment of Pain After Carpal Tunnel Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel
Keywords: pain relief
narcotic pain relief
non-narcotic pain relief
post-operative pain relief
carpal tunnel
Lead sponsor: Horizon Health Network
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: University of Michigan
name: Jefferson Medical College of Thomas Jefferson University
name: McGill University
name: University of Western Ontario, Canada
name: Sanford Health
name: Carilion Clinic
First posted: 2013-11-01
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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)

Detailed description: Participants will be provided with forms by site coordinators and will be provided in person instruction on how to fill out the pain intensity scores, the pain interference scores, the pain medication diary, and the final pain relief assessment form.

Medications will be identified only by number and will be available to the participant after standard instruction on use of medications is provided by the surgeon or research associate. Patients will be instructed - verbally and written - to take the study medication (2 capsules per dose) up to four times per day as needed for pain for 1 week or until pain free.

If patients experience intolerable discomfort, they will be able to contact personnel (24 hours on call) associated with the study to receive an alternate analgesic. The surgeon will determine if the patient is taking the maximum dose and then prescribe additional study drug or a non-study drug as an alternative. If the patient receives pain medication outside of the study protocol, the medication will be recorded, this will be recorded as a protocol violation. If this occurs in more than 20 people during the trial a per-protocol and efficacy analysis will be considered.

Participants will return to see the surgeon or designate between post-operative day 7 and 14 to return their diary, unused medication, and post-operative pain satisfaction survey. Participants will be specifically asked about: any adverse events, compliance with the program and the reason for any deviation and any other analgesic medication taken during the course of the study.

Eligibility 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

Primary outcomes:
measure: Pain relief
timeFrame: 7-15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Philadelphia Hand Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford orthopedics and Sports Medicine-Sioux Falls
state: South Dakota
city: Roanoke
country: United States
facility: CarilionClinic
state: Virginia
city: Saint John
country: Canada
facility: Horizon Health Network
state: New Brunswick
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: London
country: Canada
facility: University of Western Ontario, Canada
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Saint John, NB
name: Donald Lalonde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lalonde DH, Lalonde JF, MacDermid JC, Chung KC, Gan BS, Mierisch C, Van Demark RE Jr, Luc M. Time to Stop Routinely Prescribing Opiates after Carpal Tunnel Release. Plast Reconstr Surg. 2022 Mar 1;149(3):651-660. doi: 10.1097/PRS.0000000000008834.