Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00408707
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : February 29, 2008
Information provided by:
Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: local infiltration analgesia Phase 4

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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.
Study Start Date : September 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Primary Outcome Measures :
  1. Postoperative pain

Secondary Outcome Measures :
  1. analgésia consumption
  2. time to discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00408707

Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Principal Investigator: Lasse Andersen, M.D. Hvidovre University Hospital

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00408707     History of Changes
Other Study ID Numbers: KF01320120
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by Hvidovre University Hospital:
local infiltration analgesia
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents