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

NeuroTherapia, Inc.

Status: Completed

Conditions: Total Knee Replacement Surgery

Treatments: Procedure: ultrasound guidance and catheter stimulation; Procedure: ultrasound guidance alone; Procedure: ultrasound guidance and needle stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00927368

09-340

Details and patient eligibility

About

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.

Full 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.

Enrollment: 453 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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453 participants in 3 patient groups

Ultrasound guidance alone

Active Comparator group

Description:

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.

Treatment:

Procedure: ultrasound guidance alone

Ultrasound guidance needle stimulation

Active Comparator group

Description:

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

Treatment:

Procedure: ultrasound guidance and needle stimulation

Ultrasound guidance+catheter stimulation

Active Comparator group

Description:

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.

Treatment:

Procedure: ultrasound guidance and catheter stimulation