Clinical trial NCT05209490: Ultrasound-guided Femoral Nerve Block Without Electrical Stimulation of Peripheral Nerves
Official title: Femoral Nerve Block: Comparison of the Effectiveness of Ultrasound Control Versus Ultrasound Control With Electrical Stimulation of Peripheral Nerves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Efficiency
Femoral Nerve
Ultrasonography
Keywords: femoral nerve block
ultrasound guidance
electrical stimulation of peripheral nerves
Lead sponsor: Mogilev Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There is little work comparing the effectiveness of a femoral nerve block performed only under US guidance or US plus electrical stimulation of the peripheral nerve (EPN). The authors have shown the same effectiveness of these techniques(1).But the effectiveness of the blockade of the femoral nerve (complete blockade) performed in different ways turned out to be low valve: 71.7% for ultrasound in combination with electrical stimulation versus 69% for only ultrasound guidance.

Research hypothesis: the blockade of the femoral nerve performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.


Eligibility criteria: Inclusion Criteria:

* indication requiring anesthesia maintenance;
* patient's written consent about the type of anesthesia and possible complications of regional anesthesia

Exclusion Criteria:

* patient's refusal of application for the proposed form of anesthesia;
* patients younger than 18 years;
* patients weighing less than 50 kg;
* a physical status score of more than 3 determined by the American Society of Anesthesiologists (ASA);
* a history of allergic reactions to the drugs used;
* coagulopathies;
* infections of the skin at the injection site;
* neurological or neuromuscular diseases;
* severe liver diseases or kidney failures;
* an inability to cooperate with the patient.

Primary outcomes:
measure: Сomplete sensory femoral nerve block
timeFrame: The quality of sensory blocks was assessed after 45 minutes of administration of the sciatic nerve block. The evaluation of the block was carried out by an anesthesiologist who was not involved in the study, and was blinded to solution that had been
Secondary outcomes:
measure: Сomplete motor femoral nerve block
timeFrame: The quality of motor blocks was assessed after 45 minutes of administration of the sciatic nerve block. The evaluation of the block was carried out by an anesthesiologist who was not involved in the study, and was blinded to solution that had been
Other outcomes:
measure: The need for additional pain relief during surgery
timeFrame: During the operation (start of operation - end of operation)
Locations:
city: Mogilev
country: Belarus
facility: Mogilev Regional Clinical Hospital
Study officials:
affiliation: Mogilev Regional Clinical Hospital
name: Valery Piacherski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: lida.muzyka@yandex.by
name: Lidziya Muzyka
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sites BD, Beach ML, Chinn CD, Redborg KE, Gallagher JD. A comparison of sensory and motor loss after a femoral nerve block conducted with ultrasound versus ultrasound and nerve stimulation. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):508-13. doi: 10.1097/AAP.0b013e3181ae7306.