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)

Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves

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.

Study Overview

• Status: Recruiting
• Conditions: Ultrasonography; Nerve Block; Efficiency; Femoral Nerve; Minimum Effective Dose
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valery Piacherski, Ph.D.; Phone Number: +375445378157; Email: pechersky.v@yandex.ru
• Study Contact Backup: Name: Lidziya Muzyka; Email: lida.muzyka@yandex.by

Study Locations

• Belarus
  • Mogilev, Belarus, 212026
    • Recruiting
    • Mogilev Regional Clinical Hospital
    • Contact: Valery Piacherski, Ph.D.; Phone Number: +375445378157; Email: pechersky.v@yandex.ru
    • Contact: Lidziya Muzyka; Email: lida.muzyka@yandex.by

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FN blockade under ultrasound control with a peripheral nerve stimulator 7.5 ml 1% lidocaine; Patients undergoing surgery on the shin, ankle or foot	Procedure: Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaine; Following the ultrasound visualization of the femoral nerve, a insulated injection needle was connected to the nerve stimulator . Under ultrasound visualization guidance, the needle of the electronic nerve stimulator was positioned at the femoral nerve (in plane) from its lateral side at a slightly superior position . A marker for LA introduction was the visualization of the needle end near the nerve, and a positive muscular response . Subsequently, the introduction of LA solution was initiated (7.5 ml 1% lidocaine).If LA was spreading from the lateral side down to the nerve, then the needle was replaced to the upper point of the nerve and the rest of LA was introduced, and vice versa . The presence of a complete and incomplete spread of LA along the entire circumference of the nerve was assessed. Correspondingly, if the anesthetic was spreading upwardly, the needle would be downwardly replaced. In addition, a sciatic nerve block is performed.
Other: FN blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine; Patients undergoing surgery on the shin, ankle or foot	Procedure: Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine; Under ultrasound visualization guidance, the needle owas positioned at the femoral nerve (in plane) from its lateral side at a slightly superior position . A marker for LA introduction was the visualization of the needle end near the nerve. Subsequently, the introduction of LA solution was initiated. The position of the needle was corrected 1-2 times according to the type of anesthetic spread. If LA was spreading from the lateral side down to the nerve, then the needle was replaced to the upper point of the nerve and the rest of LA was introduced, and vice versa . The presence of a complete and incomplete spread of LA (7.5 ml 1% lidocaine) along the entire circumference of the nerve was assessed. Correspondingly, if the anesthetic was spreading upwardly, the needle would be downwardly replaced. In addition, a sciatic nerve block is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Сomplete sensory femoral nerve block	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Сomplete motor femoral nerve block	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for additional pain relief during surgery	The need for additional use of narcotic analgesics or local anesthesia during surgery (criterion-reporting of painful feelings during the operation). Based on the patient's complaint about pain of any intensity during the operation.	During the operation (start of operation - end of operation)

Collaborators and Investigators

• Sponsor: Mogilev Regional Clinical Hospital
• Investigators: Principal Investigator: Lidziya Muzyka, Mogilev Regional Clinical Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: femoral nerve block; ultrasound guidance; electrical stimulation of peripheral nerves
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 7.5ml femoral nerve

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: After publishing the data
• IPD Sharing Access Criteria: Contact us: Valery Piacherski, Ph.D.; pechersky.v@yandex.ru
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No