search
Back to results

Narcotic vs. Non-narcotic Pain Study Protocol

Primary Purpose

Carpal Tunnel

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Narcotic
non-narcotic
Sponsored by
Horizon Health Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carpal Tunnel focused on measuring pain relief, narcotic pain relief, non-narcotic pain relief, post-operative pain relief, carpal tunnel

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Philadelphia Hand Center
  • Sanford orthopedics and Sports Medicine-Sioux Falls
  • CarilionClinic
  • Horizon Health Network
  • Lawson Health Research Institute
  • University of Western Ontario, Canada
  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Narcotic

non-narcotic

Arm Description

Hydrocodone + acetaminophen 4 times per day 1 week after surgery

ibuprofen + acetaminophen 4 times per day 1 week after surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2013
Last Updated
February 24, 2022
Sponsor
Horizon Health Network
Collaborators
Lawson Health Research Institute, University of Michigan, Jefferson Medical College of Thomas Jefferson University, McGill University, University of Western Ontario, Canada, Sanford Health, Carilion Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01974609
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horizon Health Network
Collaborators
Lawson Health Research Institute, University of Michigan, Jefferson Medical College of Thomas Jefferson University, McGill University, University of Western Ontario, Canada, Sanford Health, Carilion Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purposes of this noninferiority randomized clinical trial are to: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel
Keywords
pain relief, narcotic pain relief, non-narcotic pain relief, post-operative pain relief, carpal tunnel

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narcotic
Arm Type
Experimental
Arm Description
Hydrocodone + acetaminophen 4 times per day 1 week after surgery
Arm Title
non-narcotic
Arm Type
Active Comparator
Arm Description
ibuprofen + acetaminophen 4 times per day 1 week after surgery
Intervention Type
Drug
Intervention Name(s)
Narcotic
Other Intervention Name(s)
Hydrocodone/acetaminophen
Intervention Description
Hydrocodone 5mg + acetaminophen 325 mg
Intervention Type
Drug
Intervention Name(s)
non-narcotic
Other Intervention Name(s)
ibuprofen + acetaminophen
Intervention Description
ibuprofen 600mg + acetaminophen 325 mg
Primary Outcome Measure Information:
Title
Pain relief
Description
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.
Time Frame
7-15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Lalonde, MD
Organizational Affiliation
Saint John, NB
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Philadelphia Hand Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Sanford orthopedics and Sports Medicine-Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CarilionClinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Horizon Health Network
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L4
Country
Canada
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
University of Western Ontario, Canada
City
London
State/Province
Ontario
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 0G4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35041636
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.
Results Reference
background

Learn more about this trial

Narcotic vs. Non-narcotic Pain Study Protocol

We'll reach out to this number within 24 hrs