Narcotic vs. Non-narcotic Pain Study Protocol
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| ClinicalTrials.gov Identifier: NCT01974609 |
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Recruitment Status :
Recruiting
First Posted : November 1, 2013
Last Update Posted : August 6, 2019
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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 |
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 (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 2020 |
| Estimated Study Completion Date : | March 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Narcotic
Hydrocodone + acetaminophen 4 times per day 1 week after surgery
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Drug: Narcotic
Hydrocodone 5mg + acetaminophen 325 mg
Other Name: Hydrocodone/acetaminophen |
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Active Comparator: non-narcotic
ibuprofen + acetaminophen 4 times per day 1 week after surgery
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Drug: non-narcotic
ibuprofen 600mg + acetaminophen 325 mg
Other Name: ibuprofen + acetaminophen |
- 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.
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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 |
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
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 | Completed |
| Philadelphia, Pennsylvania, United States, 19107 | |
| 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 | Completed |
| Montreal, Quebec, Canada, H3A 0G4 | |
| Principal Investigator: | Donald Lalonde, MD | Saint John, NB |
| 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: | August 6, 2019 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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pain relief narcotic pain relief non-narcotic pain relief post-operative pain relief carpal tunnel |
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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 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 Respiratory System Agents |