Narcotic vs. Non-narcotic Pain Study Protocol
Condition: Carpal Tunnel
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Narcotic; non-narcotic
Intervention type(s): Drug; Drug
Intervention description(s): Hydrocodone 5mg + acetaminophen 325 mg; ibuprofen 600mg + acetaminophen 325 mg
Other intervention name(s): Hydrocodone/acetaminophen; ibuprofen + acetaminophen
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Narcotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain relief; narcotic pain relief; non-narcotic pain relief; post-operative pain relief; carpal tunnel