Narcotic vs. Non-narcotic Pain Study Protocol
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)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- 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.
|Study Start Date:||March 2016|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Canada, New Brunswick|
|Horizon Health Network||Recruiting|
|Saint John, New Brunswick, Canada, E2L 4L4|
|Contact: Donald Lalonde email@example.com|
|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 firstname.lastname@example.org|
|Montreal, Quebec, Canada, H3A 0G4|
|Contact: Mario Luc email@example.com|
|Principal Investigator: Mario Luc, MD|
|Principal Investigator:||Donald Lalonde, MD||Saint John, NB|