Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip 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: NCT00864409
Recruitment Status : Unknown
Verified March 2009 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : March 18, 2009
Last Update Posted : March 18, 2009
Information provided by:
Hvidovre University Hospital

Brief Summary:
High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.

Condition or disease Intervention/treatment Phase
Postoperative Pain Hip Arthroplasty Drug: ropivacaine 0,2% Drug: saline.9% Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Hip 1
high volume local anesthetic infiltration
Drug: ropivacaine 0,2%
Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL

Placebo Comparator: Hip 2 Drug: saline.9%
Wound infiltration with 170 mL sterile saline

Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 0-48 hours postoperative ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • scheduled for bilateral total hip arthroplasty
  • able to speak and understand Danish

Exclusion Criteria:

  • treatment with opioids or steroids

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): NCT00864409

Contact: Lasse Andersen, MD +45 36323632

Hviovre University Hospital Recruiting
Hvidovre, Denmark, DK-2650
Contact: Lasse Andersen, MD    +45 36323632   
Sponsors and Collaborators
Hvidovre University Hospital

Responsible Party: Lasse Andersen, MD, Hvidovre University Hospital Identifier: NCT00864409     History of Changes
Other Study ID Numbers: KF-01-2006-4062
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: March 18, 2009
Last Verified: March 2009

Keywords provided by Hvidovre University Hospital:
postoperative pain
total hip arthroplasty

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