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

NCT ID: NCT05209490

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-06-30

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.

Conditions

Nerve Block; Efficiency; Femoral Nerve; Ultrasonography

Study Design

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

Study Groups

Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator

Group Type: OTHER

Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator

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 sciatic 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.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 femoral nerve block is performed.

Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator

Group Type: OTHER

femoral nerve blockade under ultrasound control without a peripheral nerve stimulator

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 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 blockade under ultrasound control with a peripheral nerve stimulator

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 sciatic 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.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 femoral nerve block is performed.

Intervention Type: PROCEDURE

femoral nerve blockade under ultrasound control without a peripheral nerve stimulator

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 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

lida.muzyka@yandex.by

Locations

Mogilev Regional Clinical Hospital

Mogilev, , Belarus

Countries

Belarus

References

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.

Reference Type: BACKGROUND

PMID: 19920428 (View on PubMed)

Other Identifiers

4 femoral block without EPN

Identifier Type: -

Identifier Source: org_study_id