Narcotic vs. Non-narcotic Pain Study Protocol

Carpal Tunnel Clinical Trial

Official title:

A Randomized, Controlled Trial Comparing Combination Therapy of Ibuprofen + Acetaminophen Versus Hydrocodone + Acetaminophen for the Treatment of Pain After Carpal Tunnel Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974609
• Other study ID #: Narcotic vs. Non-narcotic Pain
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: February 24, 2022

Study information

• Verified date: February 2022
• Source: Horizon Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome

Intervention

Drug:
• Narcotic
Hydrocodone 5mg + acetaminophen 325 mg
• non-narcotic
ibuprofen 600mg + acetaminophen 325 mg

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario
Canada	University of Western Ontario, Canada	London	Ontario
Canada	McGill University	Montreal	Quebec
Canada	Horizon Health Network	Saint John	New Brunswick
United States	The Philadelphia Hand Center	Philadelphia	Pennsylvania
United States	CarilionClinic	Roanoke	Virginia
United States	Sanford orthopedics and Sports Medicine-Sioux Falls	Sioux Falls	South Dakota

Sponsors (8)

Lead Sponsor	Collaborator
Horizon Health Network	Carilion Clinic, Jefferson Medical College of Thomas Jefferson University, Lawson Health Research Institute, McGill University, Sanford Health, University of Michigan, University of Western Ontario, Canada

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	1. Determine whether the most commonly used nonnarcotic analgesics (ibuprofen 600 mg + acetaminophen 325 mg) provide 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.	7-15 days