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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01198340
Other study ID # TKAFEMORAL-2010
Secondary ID UMIN000004155
Status Recruiting
Phase N/A
First received September 8, 2010
Last updated July 20, 2011
Start date September 2010
Est. completion date June 2012

Study information

Verified date August 2010
Source Okayama University
Contact Hideki Taninishi, MD, PhD
Phone 81-86-235-7327
Email tanishi@ops.dti.ne.jp
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patients older than 20 yrs old scheduled for total knee arthroplasty

Exclusion Criteria:

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
PC-FNB with basal administration of local anesthetics
Administration of 0.2% ropivacaine for femoral nerve block with 3 ml/h of basal dose, 5ml bolus by the patient, 60 minutes of lock out time.
PC-FNB without basal local anesthetics
Administration of 0.2% ropivacaine for femoral nerve block without basal dose, with 8 ml bolus by the patient, 60 minutes of lockout time.

Locations

Country Name City State
Japan Anesthesiology and Resuscitology, Okayama University Hospital Okayama

Sponsors (1)

Lead Sponsor Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain scores by use of numerous rating scale (NRS) 4 days after the surgery No
Secondary dose of local anesthetics 4 days after the surgery No
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