Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation

Not Applicable

Completed

• Conditions: Nerve Block; Ultrasonography; Efficiency; Sciatic Nerve
• Interventions: Other: sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator; Other: sciatic nerve blockade under ultrasound control with a peripheral nerve stimulator

• Registration Number: NCT05054881
• Lead Sponsor: Mogilev Regional Clinical Hospital

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 PEN. 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 ESP, in comparison with the blockade of the sciatic nerve performed under ultrasound control with ESP, has not been established.

Research hypothesis: the blockade of the sciatic nerve by the subgluteal approach performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-23
• Study Start: 2022-04-04
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-13
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sciatic nerve block under ultrasound control without a electrostimulator peripheral nerves	sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator	Patients undergoing surgery on the knee, shin, ankle or foot
Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves	sciatic nerve blockade under ultrasound control with a peripheral nerve stimulator	Patients undergoing surgery on the knee, shin, ankle or foot

Primary Outcome Measures

Name	Time	Method
Сomplete motor sciatic nerve block	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
Сomplete sensory sciatic nerve block	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.
The need for additional pain relief during surgery	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.

Trial Locations

Locations (1)

Mogilev Regional Clinical Hospital; 🇧🇾 Mogilev, Belarus