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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00864409
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose
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 Intervention Phase
Postoperative Pain
Hip Arthroplasty
Drug: ropivacaine 0,2%
Drug: saline.9%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 0-48 hours postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864409

Locations
Denmark
Hviovre University Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

Responsible Party: Lasse Andersen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00864409     History of Changes
Other Study ID Numbers: KF-01-2006-4062 
Study First Received: March 17, 2009
Last Updated: March 17, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on December 02, 2016