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NCT00632580 Clinical Trial

Intra- Versus Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:
Intraartikulær Versus ekstraartikulær Bolus Injektion Med Ropivacain Ved Total knæalloplastik: et Prospektivt, Randomiseret, Dobbeltblindet, Kontrolleret Studie

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00632580
Other study ID # H-D-2007-0079
Secondary ID
Status Recruiting
Phase Phase 4
First received February 28, 2008
Last updated March 17, 2009
Start date January 2008
Est. completion date July 2008

Study information
Verified date March 2009
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the optimal site for application of local anesthetics in total knee arthroplasty surgery. The hypothesis is, that improved pain relief is obtained when administering local anesthetics in the tissues sourrounding the knee joint compared to the knee joint itself.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- eligible for elective total knee arthroplasty

- able to speak and understand Danish

- able to give informed consent

Exclusion Criteria:

- alocohol or medical abuse

- allergies to local anesthetics

- age < 18 yrs.

- intolerance to opioids

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• intraarticular injection with ropivacaine

• extraarticular injection with ropivacaine

Locations
Country Name City State
Denmark Hvidovre University Hospital Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

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