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

July 20, 2011 updated by: Okayama University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Okayama, Japan, 700-8558
        • Recruiting
        • Anesthesiology and Resuscitology, Okayama University Hospital
        • Contact:
        • Principal Investigator:
          • Hideki Taninishi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With basal local anesthetics
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.
Other Names:
  • PC-FNB with basal ropivacaine administration
Experimental: Without basal local anesthetics
Procedure: 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.
Other Names:
  • PC-FAB without basal ropivacaine administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain scores by use of numerous rating scale (NRS)
Time Frame: 4 days after the surgery
4 days after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
dose of local anesthetics
Time Frame: 4 days after the surgery
4 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okayama University

Investigators

  • Principal Investigator: Hideki Taninishi, MD, PhD, Okayama University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKAFEMORAL-2010
  • UMIN000004155 (Registry Identifier: UMIN.JP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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