At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating ultrasound guidance alone, ultrasound guidance and needle stimulation, and 1 other intervention for Total Knee Replacement Surgery. Completed, enrolled 453 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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 If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned.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.