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Local Anesthetics After Total Knee Arthroplasty

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
local infiltration analgesia
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring pain, local infiltration analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to give informed oral and written consent to participate
  • Able to speak Danish

Exclusion Criteria:

  • Treatment with opioids
  • Body Mass Index > 40

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale pain score

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2007
    Last Updated
    August 20, 2007
    Sponsor
    Hvidovre University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00518674
    Brief Title
    Local Anesthetics After Total Knee Arthroplasty
    Official Title
    Local Anesthetics After Total Knee Arthroplasty: Intra- vs. Extraarticular Administration? A Randomized, Double-Blind, Placebo-Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2007 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hvidovre University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    pain, local infiltration analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    local infiltration analgesia
    Intervention Description
    local wound infiltration with 30 ml ropivacaine 0.2 % (60 mg)
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale pain score

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to give informed oral and written consent to participate Able to speak Danish Exclusion Criteria: Treatment with opioids Body Mass Index > 40
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lasse Andersen, MD
    Organizational Affiliation
    Hvidovre University Hospital, Copenhagen, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20301825
    Citation
    Andersen LO, Kristensen BB, Madsen JL, Otte KS, Husted H, Kehlet H. Wound spread of radiolabeled saline with multi- versus few-hole catheters. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):200-2. doi: 10.1097/aap.0b013e3181c7733d.
    Results Reference
    derived

    Learn more about this trial

    Local Anesthetics After Total Knee Arthroplasty

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