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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
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

First Posted
December 6, 2006
Last Updated
February 28, 2008
Sponsor
Hvidovre University Hospital
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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

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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty

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