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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

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ClinicalTrials.gov 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
Sponsor:
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

U.S. FDA Resources

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00864409


Contacts
Contact: Lasse Andersen, MD +45 36323632 lasse.oestergaard.andersen@hvh.regionh.dk

Locations
Denmark
Hviovre University Hospital Recruiting
Hvidovre, Denmark, DK-2650
Contact: Lasse Andersen, MD    +45 36323632    lasse.oestergaard.andersen@hvh.regionh.dk   
Sponsors and Collaborators
Hvidovre University Hospital

Responsible Party: Lasse Andersen, MD, Hvidovre University Hospital
ClinicalTrials.gov 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
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents