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

NCT05209490 | Completed

• 1 other identifier: 4 femoral block without EPN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

femoral nerve block; ultrasound guidance; electrical stimulation of peripheral nerves

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• The need for additional pain relief during surgery

  During the operation (start of operation - end of operation)

Study Arms (2)

Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator

OTHER

Procedure: Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator

Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator

OTHER

Procedure: femoral nerve blockade under ultrasound control without a peripheral nerve stimulator

Interventions

Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator 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 with a peripheral nerve stimulator

femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 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.

Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication requiring anesthesia maintenance;
• patient's written consent about the type of anesthesia and possible complications of regional anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mogilev Regional Clinical Hospital: lead

Study Sites (1)

Mogilev Regional Clinical Hospital

Mogilev, 212026, Belarus

Location

Related Publications (1)

• 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.

  PMID: 19920428 BACKGROUND

Study Officials

• Valery Piacherski, Ph.D.

  Mogilev Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

• Lidziya Muzyka

  lida.muzyka@yandex.by

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: February 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After publishing the data
• Access Criteria: Contact us: Valery Piacherski, Ph.D.; pechersky.v@yandex.ru

Locations

BE (1)