Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves (Influence of the Femoral Nerve Blockade on the Effectiveness of Small Doses of Local Anesthetic.). (EPBwEPN)

Not Applicable

• Conditions: Ultrasonography; Femoral Nerve; Nerve Block; Minimum Effective Dose; Efficiency
• Interventions: Procedure: Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaine; Procedure: Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine

• Registration Number: NCT05209711
• Lead Sponsor: Mogilev Regional Clinical Hospital

Brief Summary

In modern anesthesiology, peripheral nerve blocks are performed using ultrasound control and electrical stimulation of peripheral nerves (PEN), or only ultrasound control or only EPN. The most effective methods are with the use of ultrasound control. Until now, the effectiveness of the femoral nerve blockade, performed only under ultrasound control without EPN, in comparison with the blockade of the femoral nerve performed under ultrasound control with EPN, has not been established.

There is no data on how the effectiveness of the blockade of the femoral nerve with small doses of lidocaine is influenced by the method of performing the blockade: under ultrasound control versus ultrasound control with electrostimulation of the nerve.

Research hypothesis: the blockade of the femoral nerve (7.5 ml 1%lidocaine -Minimum Effective Dose - previously established ) 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: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Study Start: 2022-02-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• 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
FN blockade under ultrasound control with a peripheral nerve stimulator 7.5 ml 1% lidocaine	Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaine	Patients undergoing surgery on the shin, ankle or foot
FN blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine	Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine	Patients undergoing surgery on the shin, ankle or foot

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