Ultrasound-guided Femoral Nerve Block Without Electrical Stimulation of Peripheral Nerves

Not Applicable

Completed

• Conditions: Nerve Block; Efficiency; Ultrasonography; Femoral Nerve
• Interventions: Procedure: femoral nerve blockade under ultrasound control without a peripheral nerve stimulator; Procedure: Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator

• Registration Number: NCT05209490
• Lead Sponsor: Mogilev Regional Clinical Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2022-02-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator	femoral nerve blockade under ultrasound control without a peripheral nerve stimulator	-
Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator	Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator	-

Primary Outcome Measures

Name	Time	Method
Сomplete sensory femoral nerve block	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	The stimulus of the needle prick was applied to check the sensory block of thefemoral nerve. The assessment of skin sensitivity was carried out with the help of a similar scale: + +\\ indicating a complete sensory block; +\\ indicating a partial sensory block, a patient was unable to differentiate between the type of stimuli ; and -\\ indicating that the skin sensitivity was fully preserved.

Secondary Outcome Measures

Name	Time	Method
Сomplete motor femoral nerve block	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	The assessment of the motor block was carried out with the help of the following scale: + +\\ which indicated that movements were completely absent; +\\ which indicated that movements were partially preserved or were uncoordinated; and -\\ which indicated that movements were fully preserved.

Trial Locations

Locations (1)

Mogilev Regional Clinical Hospital; 🇧🇾 Mogilev, Belarus