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Clinical Trials/NCT05205473
NCT05205473
Completed
Not Applicable

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.).

Mogilev Regional Clinical Hospital1 site in 1 country40 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nerve Block
Sponsor
Mogilev Regional Clinical Hospital
Enrollment
40
Locations
1
Primary Endpoint
Сomplete sensory sciatic nerve block
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
May 16, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mogilev Regional Clinical Hospital
Responsible Party
Principal Investigator
Principal Investigator

Valery Piacherski, Ph.D.

Chief of the Department of Anesthesiology and Intensive Care

Mogilev Regional Clinical Hospital

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.

Outcomes

Primary Outcomes

Сomplete sensory sciatic nerve block

Time Frame: 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

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.

Сomplete motor sciatic nerve block

Time Frame: 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 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 need for additional pain relief during surgery

Time Frame: During the operation (start of operation - end of operation)

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.

Study Sites (1)

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