Comparison of 3 Techniques for Ultrasound-guided Femoral Nerve Catheter Insertion

Study Overview
=================
Brief Summary
-----------------
This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.

Detailed Description
-----------------
This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation. Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10. Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed. Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery. Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.

Official Title
-----------------
Comparison Between Ultrasound Guided Femoral Nerve Block Versus Ultrasound Guided Femoral Nerve Block With the Use of Peripheral Nerve Stimulation for Patients Undergoing Total Knee Replacement.

Conditions
-----------------
Total Knee Replacement Surgery

Intervention / Treatment
-----------------
* Procedure: ultrasound guidance alone
* Procedure: ultrasound guidance and needle stimulation
* Procedure: ultrasound guidance and catheter stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old at time of surgery. Male or female patients undergoing total knee replacement under either general or neuraxial anesthesia (spinal or epidural). Intraoperative, patients will receive spinal anesthetics with 15 mg bupivacaine and 25mcg of fentanyl intrathecally. Exclusion Criteria: Current or recent drug abuse (within past 6 months). Pregnancy. Patient refuses regional analgesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guidance alone<br>The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. | Procedure: ultrasound guidance alone<br>* The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.<br>|
| Active Comparator: Ultrasound guidance needle stimulation<br>For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation | Procedure: ultrasound guidance and needle stimulation<br>* For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.<br>|
| Active Comparator: Ultrasound guidance+catheter stimulation<br>For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA. | Procedure: ultrasound guidance and catheter stimulation<br>* The Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Weighted Average Verbal Response Scale Pain Score | Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable). Verbal Response Scale (VRS) pain scores after surgery - which ranged from 0 (no pain) to 10 (maximum intolerable pain) - were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.). | 48 hours after surgery | 
| Opioid Consumption | cumulative opioid consumption, where all opioids were converted to IV morphine equivalents | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block Performance Time | Block performance time, defined as the time from block start until catheter placement. | time elapsed from beginning the block to catheter placement | 
| Incremental Cost of Femoral Nerve Blocks | The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate. | postoperative period when block is used | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKA, total knee replacement