Narcotic vs. Non-narcotic Pain Study Protocol

February 24, 2022 updated by: Don Lalonde MD, Horizon Health Network

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L4
        • Horizon Health Network
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Lawson Health Research Institute
      • London, Ontario, Canada
        • University of Western Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 0G4
        • McGill University
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • The Philadelphia Hand Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford orthopedics and Sports Medicine-Sioux Falls
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • CarilionClinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narcotic
Hydrocodone + acetaminophen 4 times per day 1 week after surgery
Drug: Narcotic
Hydrocodone 5mg + acetaminophen 325 mg
Other Names:
  • Hydrocodone/acetaminophen
Active Comparator: non-narcotic
ibuprofen + acetaminophen 4 times per day 1 week after surgery
Drug: non-narcotic
ibuprofen 600mg + acetaminophen 325 mg
Other Names:
  • ibuprofen + acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 7-15 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horizon Health Network

Collaborators

McGill University
University of Michigan
Carilion Clinic
Lawson Health Research Institute
University of Western Ontario, Canada
Jefferson Medical College of Thomas Jefferson University
Sanford Health

Investigators

  • Principal Investigator: Donald Lalonde, MD, Saint John, NB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

February 24, 2022

Study Completion (Actual)

February 24, 2022

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Narcotic vs. Non-narcotic Pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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