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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00518674
Other study ID # KF01329190
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 20, 2007
Last updated August 20, 2007
Start date January 2007
Est. completion date September 2007

Study information

Verified date July 2007
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

The aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Able to give informed oral and written consent to participate

- Able to speak Danish

Exclusion Criteria:

- Treatment with opioids

- Body Mass Index > 40

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
local infiltration analgesia
local wound infiltration with 30 ml ropivacaine 0.2 % (60 mg)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale pain score
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