Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

June 4, 2013 updated by: Troels Haxholdt Lunn, Hvidovre University Hospital

Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid

Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Dep. of ortopedic surgery, Gentofte Hospital
      • Holstebro, Denmark, 7500
        • Dep. of ortopedic surgery, Regionshospitalet Holstebro
      • Vejle, Denmark, 7100
        • Dep. of ortopedic surgery, Vejle Sygehus
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, 2650
        • Dep. of Anesthesiology, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients operated with elective, primary, unilateral total knee artroplasty (TKA).

Description

Inclusion Criteria:

Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)

Exclusion Criteria:

  • Bilateral / revision arthroplasty
  • Disease affection central or peripheral nerve function
  • Alcohol and medical abuse
  • Daily use of glucocorticoids
  • Malignancy
  • BMI > 40
  • Dementia or other cognitive dysfunction
  • Treatment of anxiety or depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Strong opioids
Patients taking strong opioids preoperatively
Weak opioids
Patients taking weak opioids preoperatively
Opioid native
Patients not taking opioids preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 24 hours
Pain during ambulation and at rest
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 7 days
Pain during ambulation and at rest
7 days
Opioid consumption
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Troels H Lunn, MD, Dep. of Anesthesiology, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11123111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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