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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Procedure: Femoral nerve block; Procedure: Femoral nerve block non stimulating catheter; Procedure: Femoral nerve block stimulating catheter

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Anesthesia Pain Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Numeric Rating Pain Score	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.	Postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ability to move the knee	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.	Postoperative
Change in Supplemental pain medications	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.	Postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the overall satisfaction	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.	Postoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Advocate-IRB-5235