NCT01198340

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 22, 2011

Status Verified

August 1, 2010

Enrollment Period

1.5 years

First QC Date

September 8, 2010

Last Update Submit

July 20, 2011

Conditions

Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (1)

  • pain scores by use of numerous rating scale (NRS)

    4 days after the surgery

Secondary Outcomes (1)

  • dose of local anesthetics

    4 days after the surgery

Study Arms (2)

With basal local anesthetics

ACTIVE COMPARATOR
Procedure: PC-FNB with basal administration of local anesthetics

Without basal local anesthetics

EXPERIMENTAL
Procedure: PC-FNB without basal local anesthetics

Interventions

PC-FNB with basal administration of local anestheticsPROCEDURE

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.

Also known as: PC-FNB with basal ropivacaine administration
With basal local anesthetics
PC-FNB without basal local anestheticsPROCEDURE

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

Also known as: PC-FAB without basal ropivacaine administration
Without basal local anesthetics

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Resuscitology, Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

RECRUITING

Study Officials

  • Hideki Taninishi, MD, PhD

    Okayama University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hideki Taninishi, MD, PhD

CONTACT

81-86-235-7327tanishi@ops.dti.ne.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

July 22, 2011

Record last verified: 2010-08

Locations

JP(1)