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

Primary Purpose

Arthropathy of Knee Joint

Status

Unknown status

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

PC-FNB with basal administration of local anesthetics

PC-FNB without basal local anesthetics

About this trial

This is an interventional treatment trial for Arthropathy of Knee Joint

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients older than 20 yrs old scheduled for total knee arthroplasty

Exclusion Criteria:

none

Sites / Locations

Anesthesiology and Resuscitology, Okayama University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

With basal local anesthetics

Without basal local anesthetics

Arm Description

Outcomes

Primary Outcome Measures

pain scores by use of numerous rating scale (NRS)

Secondary Outcome Measures

dose of local anesthetics

Full Information

NCT ID

NCT01198340

First Posted

September 8, 2010

Last Updated

July 20, 2011

Sponsor

Okayama University

1. Study Identification

Unique Protocol Identification Number

NCT01198340

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Okayama University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthropathy of Knee Joint

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

With basal local anesthetics

Arm Type

Active Comparator

Arm Title

Without basal local anesthetics

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

PC-FNB with basal administration of local anesthetics

Other Intervention Name(s)

PC-FNB with basal ropivacaine administration

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

PC-FNB without basal local anesthetics

Other Intervention Name(s)

PC-FAB without basal ropivacaine administration

Intervention Description

Administration of 0.2% ropivacaine for femoral nerve block without basal dose, with 8 ml bolus by the patient, 60 minutes of lockout time.

Primary Outcome Measure Information:

Title

pain scores by use of numerous rating scale (NRS)

Time Frame

4 days after the surgery

Secondary Outcome Measure Information:

Title

dose of local anesthetics

Time Frame

4 days after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients older than 20 yrs old scheduled for total knee arthroplasty Exclusion Criteria: none

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hideki Taninishi, MD, PhD

Phone

81-86-235-7327

tanishi@ops.dti.ne.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hideki Taninishi, MD, PhD

Organizational Affiliation

Okayama University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anesthesiology and Resuscitology, Okayama University Hospital

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hideki Taninishi, MD, PhD

Phone

81-86-235-7327

tanishi@ops.dti.ne.jp

First Name & Middle Initial & Last Name & Degree

Hideki Taninishi, MD, PhD

12. IPD Sharing Statement

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

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