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Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01323179
Collaborator
(none)
140
Enrollment
4
Locations
23.1
Duration (Months)
35
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid
    Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Feb 1, 2013
    Actual Study Completion Date :
    Feb 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Strong opioids

    Patients taking strong opioids preoperatively
    Weak opioids

    Patients taking weak opioids preoperatively
    Opioid native

    Patients not taking opioids preoperatively

    Outcome Measures

    Primary Outcome Measures

    1. Pain [24 hours]

      Pain during ambulation and at rest

    Secondary Outcome Measures

    1. Pain [7 days]

      Pain during ambulation and at rest

    2. Opioid consumption [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dep. of Anesthesiology, Hvidovre University Hospital Copenhagen Hvidovre Denmark 2650
    2 Dep. of ortopedic surgery, Gentofte Hospital Hellerup Denmark 2900
    3 Dep. of ortopedic surgery, Regionshospitalet Holstebro Holstebro Denmark 7500
    4 Dep. of ortopedic surgery, Vejle Sygehus Vejle Denmark 7100

    Sponsors and Collaborators

    • Hvidovre University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Troels Haxholdt Lunn, MD, Hvidovre University Hospital
    ClinicalTrials.gov Identifier:
    NCT01323179
    Other Study ID Numbers:
    • 11123111
    First Posted:
    Mar 25, 2011
    Last Update Posted:
    Jun 5, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by Troels Haxholdt Lunn, MD, Hvidovre University Hospital
    Postoperative pain
    Postoperative opioid requirements
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Jun 5, 2013