Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic

June 23, 2009 updated by: Hvidovre University Hospital

Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic.

Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee arthroplasty in 16 patients undergoing bilateral knee arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

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
      • Hvidovre, Denmark, 2650
        • 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

Description

Inclusion Criteria:

  • total bilateral knee arthroplasty

Exclusion Criteria:

  • immunological diseases
  • treatment with opioids or steroids
  • allergy to any drugs administered

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active
subcutaneous wound infiltration with 50 mL ropivacaine 0.2%
Drug: ropivacaine 0.2%, 50 mL
Placebo Comparator: placebo
subcutaneous wound infiltration with 50 mL saline
Drug: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain
Time Frame: 1-6 hours postoperative
1-6 hours postoperative

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

June 24, 2009

Last Update Submitted That Met QC Criteria

June 23, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2008-104

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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