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
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|
|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|
Hydrocodone + acetaminophen 4 times per day 1 week after surgery
Hydrocodone 5mg + acetaminophen 325 mg
Other Name: Hydrocodone/acetaminophen
Active Comparator: non-narcotic
ibuprofen + acetaminophen 4 times per day 1 week after surgery
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.
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
|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|
|Roanoke, Virginia, United States, 24014|
|Canada, New Brunswick|
|Horizon Health Network|
|Saint John, New Brunswick, Canada, E2L 4L4|
|Lawson Health Research Institute|
|London, Ontario, Canada, N6A 4V2|
|University of Western Ontario, Canada|
|London, Ontario, Canada|
|Montreal, Quebec, Canada, H3A 0G4|
|Principal Investigator:||Donald Lalonde, MD||Saint John, NB|