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)

NCT ID: NCT05209711

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-10-31

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.

Conditions

Nerve Block; Efficiency; Femoral Nerve; Ultrasonography; Minimum Effective Dose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

FN blockade under ultrasound control with a peripheral nerve stimulator 7.5 ml 1% lidocaine

Patients undergoing surgery on the shin, ankle or foot

Group Type: OTHER

Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaine

Intervention Type: PROCEDURE

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.

FN blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine

Patients undergoing surgery on the shin, ankle or foot

Group Type: OTHER

Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mogilev Regional Clinical Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Valery Piacherski, Ph.D.

Chief of the Department of Anesthesiology and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valery Piacherski, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mogilev Regional Clinical Hospital

Lidziya Muzyka

Role: PRINCIPAL_INVESTIGATOR

Mogilev Regional Clinical Hospital

Locations

Mogilev Regional Clinical Hospital

Mogilev, , Belarus

Site Status: RECRUITING

Countries

Belarus

Central Contacts

Valery Piacherski, Ph.D.

Role: CONTACT

pechersky.v@yandex.ru

+375445378157

Lidziya Muzyka

Role: CONTACT

lida.muzyka@yandex.by

Facility Contacts

Valery Piacherski, Ph.D.

Role: primary

pechersky.v@yandex.ru

+375445378157

Lidziya Muzyka

Role: backup

lida.muzyka@yandex.by

Other Identifiers

7.5ml femoral nerve

Identifier Type: -

Identifier Source: org_study_id