NCT01974609

Narcotic vs. Non-narcotic Pain Study Protocol

A Randomized, Controlled Trial Comparing Combination Therapy of Ibuprofen + Acetaminophen Versus Hydrocodone + Acetaminophen for the Treatment of Pain After Carpal Tunnel Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Horizon Health Network · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Carpal Tunnel

Interventions

Type	Name	Description
DRUG	Narcotic	Hydrocodone 5mg + acetaminophen 325 mg
DRUG	non-narcotic	ibuprofen 600mg + acetaminophen 325 mg

Timeline

• Start date: 2016-03-01
• Primary completion: 2022-02-24
• Completion: 2022-02-24
• First posted: 2013-11-01
• Last updated: 2022-03-11

Locations

7 sites across 2 countries: United States, Canada