Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty

NCT ID: NCT01763814

Last Updated: 2019-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2019-04-30

Brief Summary

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Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.

Detailed Description

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This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups:

Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter

Conditions

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Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Single shot femoral nerve block

A ultrasound probe will be used to identify the nerve, and correct needle placement.

Group Type ACTIVE_COMPARATOR

Femoral nerve block

Intervention Type PROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement.

Femoral nerve block non stimulating catheter

A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off.

Group Type ACTIVE_COMPARATOR

Femoral nerve block

Intervention Type PROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement.

Femoral nerve block non stimulating catheter

Intervention Type PROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.

Femoral nerve block stimulating catheter

A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on.

Group Type ACTIVE_COMPARATOR

Femoral nerve block

Intervention Type PROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement.

Femoral nerve block stimulating catheter

Intervention Type PROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.

Interventions

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Femoral nerve block

A visible or palpable cephalad movement of the patella will confirm needle placement.

Intervention Type PROCEDURE

Femoral nerve block non stimulating catheter

A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.

Intervention Type PROCEDURE

Femoral nerve block stimulating catheter

A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18- 90 years old
* Scheduled for total knee arthroplasty

Exclusion Criteria

* Redo surgery on the same knee
* BMI ≥45
* Radicular pain in the same leg
* Allergy to local anesthetics
* Opioid habituation
* Pregnancy
* Contraindication to regional block
* Inability to communicate with hospital staff or investigators.
* Neuropathy of any etiology in the surgical extremity.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chicago Anesthesia Pain Specialists

OTHER

Sponsor Role lead

Responsible Party

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Antony Tharian

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antony Tharian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chicago Anesthesia Pain Specialists

Locations

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Chicago Anesthesia Pain Specialists

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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Advocate-IRB-5235

Identifier Type: -

Identifier Source: org_study_id

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