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

Study Overview
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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

Official Title
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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

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Procedure: Femoral nerve block
* Procedure: Femoral nerve block non stimulating catheter
* Procedure: Femoral nerve block stimulating catheter


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single shot femoral nerve block<br>A ultrasound probe will be used to identify the nerve, and correct needle placement. | Procedure: Femoral nerve block<br>* A visible or palpable cephalad movement of the patella will confirm needle placement.<br>|
| Active Comparator: Femoral nerve block non stimulating catheter<br>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<br>* A visible or palpable cephalad movement of the patella will confirm needle placement.<br>Procedure: Femoral nerve block non stimulating catheter<br>* A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.<br>|
| Active Comparator: Femoral nerve block stimulating catheter<br>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<br>* A visible or palpable cephalad movement of the patella will confirm needle placement.<br>Procedure: Femoral nerve block stimulating catheter<br>* A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.<br>|

What is the study measuring?
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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 |