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Narcotic vs. Non-narcotic Pain Study Protocol

NCT01974609 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2022-03-11

No results posted yet for this study

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)

Conditions

  • Carpal Tunnel

Interventions

DRUG

Narcotic

Hydrocodone 5mg + acetaminophen 325 mg

DRUG

non-narcotic

ibuprofen 600mg + acetaminophen 325 mg

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Jefferson Medical College of Thomas Jefferson University

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • University of Western Ontario, Canada

    collaborator OTHER

  • Sanford Health

    collaborator OTHER

  • Carilion Clinic

    collaborator OTHER

  • Horizon Health Network

    lead OTHER

Principal Investigators

  • Donald Lalonde, MD · Saint John, NB

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2022-02-24
Completion
2022-02-24

Countries

  • United States
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01974609 on ClinicalTrials.gov