Narcotic vs. Non-narcotic Pain Study Protocol

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ClinicalTrials.gov Identifier: NCT01974609

Recruitment Status : Active, not recruiting

First Posted : November 1, 2013

Last Update Posted : February 9, 2021

Sponsor:

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

Information provided by (Responsible Party):

Don Lalonde MD, Horizon Health Network

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)

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel	Drug: Narcotic Drug: non-narcotic	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Supportive Care
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 Start Date :	March 2016
Estimated Primary Completion Date :	September 30, 2021
Estimated Study Completion Date :	September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Carpal tunnel syndrome

MedlinePlus related topics: Carpal Tunnel Syndrome

Drug Information available for: Acetaminophen Hydrocodone Hydrocodone bitartrate Hycodan Ibuprofen Ibuprofen sodium Ibuprofen lysine Midol

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsies Roussy Levy Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Narcotic Hydrocodone + acetaminophen 4 times per day 1 week after surgery	Drug: Narcotic Hydrocodone 5mg + acetaminophen 325 mg Other Name: 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 Name: ibuprofen + acetaminophen

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974609

Locations

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

Sponsors and Collaborators

Horizon Health Network

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

Investigators

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Principal Investigator:	Donald Lalonde, MD	Saint John, NB

More Information

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Responsible Party:	Don Lalonde MD, MD, Horizon Health Network
ClinicalTrials.gov Identifier:	NCT01974609
Other Study ID Numbers:	Narcotic vs. Non-narcotic Pain
First Posted:	November 1, 2013 Key Record Dates
Last Update Posted:	February 9, 2021
Last Verified:	July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Don Lalonde MD, Horizon Health Network:


pain relief narcotic pain relief non-narcotic pain relief post-operative pain relief carpal tunnel

Additional relevant MeSH terms:

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Carpal Tunnel Syndrome Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Acetaminophen Ibuprofen Acetaminophen, hydrocodone drug combination Hydrocodone Narcotics	Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Central Nervous System Depressants Antitussive Agents

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