Sciatic Nerve Blockade by Subgluteal Access 12.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves (Influence of the Sciatic Nerve Blockade on the Effectiveness of Small Doses of Local Anesthetic.).

NCT05205473 | Completed

• 1 other identifier: 12.5ml sciatic nerve
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 sciatic nerve blockade by the subgluteal approach, performed only under ultrasound control without EPN, in comparison with the blockade of the sciatic nerve performed under ultrasound control with EPN, has not been established. There is no data on how the effectiveness of the blockade of the sciatic 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 sciatic nerve by the subgluteal approach (12.5 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; Sciatic Nerve; Ultrasonography; Minimum Effective Dose

Keywords

sciatic nerve block; ultrasound guidance; electrical stimulation of peripheral nerves; lidocaine; Аnesthetics Local; Minimum Effective Dose

Outcome Measures

Primary Outcomes (3)

• Сomplete sensory sciatic nerve block

  The stimulus of the needle prick was applied to check the sensory block of the sciatic nerve. Stimulation with a needle is carried out in the area of innervation of the sciatic nerve below the knee 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 min 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

• Сomplete motor sciatic 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.Flexion-extension of the foot and toes is assessed

  The quality of motor blocks was assessed after 45 min 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 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)

Study Arms (2)

SN blockade under ultrasound control with a peripheral nerve stimulator 12.5 ml 1% lidocaine

ACTIVE COMPARATOR

Patients undergoing surgery on the knee, shin, ankle or foot

Procedure: Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves 12.5 ml 1% lidocaine

SN blockade under ultrasound control without a peripheral nerve stimulator

EXPERIMENTAL

Patients undergoing surgery on the knee, shin, ankle or foot

Procedure: sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator 12.5 ml 1% lidocaine

Interventions

Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves 12.5 ml 1% lidocaine 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 (12.5 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 femoral nerve block is performed.

Also known as: Anesthesia for lower limb surgery

SN blockade under ultrasound control with a peripheral nerve stimulator 12.5 ml 1% lidocaine

sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator 12.5 ml 1% lidocaine PROCEDURE

Under ultrasound visualization guidance, the needle owas 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. 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 (12.5 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 femoral nerve block is performed.

Also known as: Anesthesia for lower limb surgery

SN 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

MeSH Terms

Interventions

Lidocaine; Anesthesia

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia and Analgesia

Study Officials

• Valery Piacherski

  Mogilev Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

• Lidziya Muzyka

  Mogilev Regional Clinical Hospital

  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 11, 2022
• First Posted: January 25, 2022
• Study Start: February 1, 2022
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: August 9, 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)