Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408707
• Other study ID #: KF01320120
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2006
• Last updated: February 28, 2008
• Start date: September 2006
• Est. completion date: December 2006

Study information

• Verified date: February 2008
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• local infiltration analgesia

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain
Secondary	analgésia consumption
Secondary	time to discharge