Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain	Procedure: local infiltration analgesia	Phase IV

MedlinePlus related topics:

Knee Replacement

Drug Information available for:

Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

Postoperative pain

Secondary Outcome Measures:

analgésia consumption
time to discharge

Estimated Enrollment:	16
Study Start Date:	September 2006
Study Completion Date:	December 2006

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408707

Locations


Denmark
	Hvidovre University Hospital
	Hvidovre, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators


Principal Investigator:	Lasse Andersen, M.D.	Hvidovre University Hospital

More Information

Study ID Numbers:	KF01320120
First Received:	December 6, 2006
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00408707
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:

local infiltration analgesia

postoperative pain

ropivacaine

Study placed in the following topic categories:

Signs and Symptoms

Postoperative Complications

Ropivacaine

Pain

Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Anesthetics

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

Anesthetics, Local

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00408707