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

Sponsor

Chicago Anesthesia Pain Specialists (Other)

Overall Status

Completed

CT.gov ID

NCT01763814

Collaborator

(none)

108

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroplasty	Procedure: Femoral nerve block Procedure: Femoral nerve block non stimulating catheter Procedure: Femoral nerve block stimulating catheter	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single shot femoral nerve block A ultrasound probe will be used to identify the nerve, and correct needle placement.	Procedure: Femoral nerve block A visible or palpable cephalad movement of the patella will confirm needle placement.
Active Comparator: 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.	Procedure: Femoral nerve block A visible or palpable cephalad movement of the patella will confirm needle placement. 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.
Active Comparator: 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.	Procedure: Femoral nerve block A visible or palpable cephalad movement of the patella will confirm needle placement. 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.

Arm

Intervention/Treatment

Active Comparator: Single shot femoral nerve block

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

Procedure: Femoral nerve block

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

Active Comparator: 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.

Procedure: Femoral nerve block

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

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.

Active Comparator: 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.

Procedure: Femoral nerve block

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

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.

Outcome Measures

Primary Outcome Measures

Change in the Numeric Rating Pain Score [Postoperative]
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.

Secondary Outcome Measures

Change in the ability to move the knee [Postoperative]
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.
Change in Supplemental pain medications [Postoperative]
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.

Other Outcome Measures

Change in the overall satisfaction [Postoperative]
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chicago Anesthesia Pain Specialists	Chicago	Illinois	United States	60657

Sponsors and Collaborators

Chicago Anesthesia Pain Specialists

Investigators

Principal Investigator: Antony Tharian, M.D., Chicago Anesthesia Pain Specialists

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antony Tharian, MD, Chicago Anesthesia Pain Specialists

ClinicalTrials.gov Identifier:

NCT01763814

Other Study ID Numbers:

Advocate-IRB-5235

First Posted:

Jan 9, 2013

Last Update Posted:

Jun 7, 2019

Last Verified:

Jun 1, 2019

Study Results

No Results Posted as of Jun 7, 2019