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Narcotic vs. Non-narcotic Pain Study Protocol

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ClinicalTrials.gov Identifier: NCT01974609
Recruitment Status : Recruiting
First Posted : November 1, 2013
Last Update Posted : August 31, 2017
Information provided by (Responsible Party):

Study Description
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)

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

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 : March 2019
Estimated Study Completion Date : March 2019

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 :
  1. 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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Contact: Donald Lalonde, MD 506-648-7950
Contact: Joy MacDermid, PhD 519-646-6100 ext 64636

United States, Pennsylvania
The Philadelphia Hand Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Patrick Kane, MD         
United States, South Dakota
Sanford orthopedics and Sports Medicine-Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Robert Van Demark, MD    605-328-1368    Robert.VanDemarkJr@SanfordHealth.org   
Contact: Angela Van Veldhuizen    605-328-1368    Angela.Vanveldhuizen@SanfordHealth.org   
United States, Virginia
CarilionClinic Recruiting
Roanoke, Virginia, United States, 24014
Contact: Cassandra Mierisch, MD    540-588-8076    crmierisch@carilionclinic.org   
Canada, New Brunswick
Horizon Health Network Recruiting
Saint John, New Brunswick, Canada, E2L 4L4
Contact: Donald Lalonde       dlalonde@drlalonde.ca   
Canada, Ontario
Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 4V2
Principal Investigator: Joy MacDermid, PhD         
University of Western Ontario, Canada Recruiting
London, Ontario, Canada
Contact: Bing Gan       bsgan@rogers.com   
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada, H3A 0G4
Contact: Mario Luc       mario.luc@mcgill.ca   
Principal Investigator: Mario Luc, MD         
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
Principal Investigator: Donald Lalonde, MD Saint John, NB
More Information

Responsible Party: Don Lalonde MD, MD, Horizon Health Network
ClinicalTrials.gov Identifier: NCT01974609     History of Changes
Other Study ID Numbers: Narcotic vs. Non-narcotic Pain
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
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:
Carpal Tunnel Syndrome
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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