- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00408707
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty
February 28, 2008 updated by: Hvidovre University Hospital
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.
The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Total knee arthroplasty (TKA) is increasingly common in the treatment of osteoarthrosis.
Despite aggressive analgesic regimes, TKA is associated with moderate to severe postoperative pain, delaying mobilization and hospital discharge.
A relatively new method for controlling postoperative pain after TKA is local infiltration analgesia (LIA) which consists of local infiltration with Ropivacaine and adrenaline.3
studies haved showed promising results of LIA, but none have documented a superior analgesic effect versus placebo.Patients receiving bilateral knee arthroplasty are recruited to receive LIA and placebo infiltration.The aim of the study is to demonstrate an analgesic effect of LIA versus placebo.
Study Type
Interventional
Enrollment (Anticipated)
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
-
-
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Hvidovre, Denmark, 2650
- Hvidovre University Hospital
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients eligible for total knee arthroplasty
- must speak and understand Danish
- must be able to give oral and written consent
Exclusion Criteria:
- Alcohol or medicine abuse
- Treatment with opioids
- Allergy to local anaesthetics
- Severe obesity
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: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Postoperative pain
|
Secondary Outcome Measures
Outcome Measure |
---|
time to discharge
|
analgésia consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lasse Andersen, M.D., Hvidovre University Hospital
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.
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, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
December 6, 2006
First Submitted That Met QC Criteria
December 6, 2006
First Posted (Estimate)
December 7, 2006
Study Record Updates
Last Update Posted (Estimate)
February 29, 2008
Last Update Submitted That Met QC Criteria
February 28, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KF01320120
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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