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NCT00864409 Clinical Trial

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00864409
Other study ID # KF-01-2006-4062
Secondary ID
Status Recruiting
Phase Phase 4
First received March 17, 2009
Last updated March 17, 2009

Study information
Verified date March 2009
Source Hvidovre University Hospital
Contact Lasse Andersen, MD
Phone +45 36323632
Email lasse.oestergaard.andersen@hvh.regionh.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- scheduled for bilateral total hip arthroplasty

- able to speak and understand Danish

Exclusion Criteria:

- treatment with opioids or steroids

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ropivacaine 0,2%
Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL
• saline.9%
Wound infiltration with 170 mL sterile saline

Locations
Country Name City State
Denmark Hviovre University Hospital Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative pain 0-48 hours postoperative No
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