Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
local infiltration analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring local infiltration analgesia, postoperative pain, ropivacaine
Eligibility Criteria
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
Sites / Locations
- Hvidovre University Hospital
Outcomes
Primary Outcome Measures
Postoperative pain
Secondary Outcome Measures
analgésia consumption
time to discharge
Full Information
NCT ID
NCT00408707
First Posted
December 6, 2006
Last Updated
February 28, 2008
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00408707
Brief Title
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty
Official Title
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
local infiltration analgesia, postoperative pain, ropivacaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
local infiltration analgesia
Primary Outcome Measure Information:
Title
Postoperative pain
Secondary Outcome Measure Information:
Title
analgésia consumption
Title
time to discharge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lasse Andersen, M.D.
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19025523
Citation
Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
Results Reference
derived
Learn more about this trial
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty
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