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

Not Applicable

Completed

• Conditions: Knee Arthroplasty
• Interventions: Procedure: Femoral nerve block; Procedure: Femoral nerve block non stimulating catheter; Procedure: Femoral nerve block stimulating catheter

• Registration Number: NCT01763814
• Lead Sponsor: Chicago Anesthesia Pain Specialists

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.

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2018-02
• Study Completion: 2019-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve block non stimulating catheter	Femoral nerve block	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.
Single shot femoral nerve block	Femoral nerve block	A ultrasound probe will be used to identify the nerve, and correct needle placement.
Femoral nerve block stimulating catheter	Femoral nerve block	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.
Femoral nerve block non stimulating catheter	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.
Femoral nerve block stimulating catheter	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Chicago Anesthesia Pain Specialists; 🇺🇸 Chicago, Illinois, United States