Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block

Arthropathy of Knee Joint Clinical Trial

Official title:

Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block With Sciatic Nerve Block After Total Knee Arthroplasty

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

• Arthropathy of Knee Joint

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