Clinical trial NCT05054881: Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation
Official title: Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation in Lower Limb Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Efficiency
Sciatic Nerve
Ultrasonography
Keywords: sciatic nerve block
ultrasound guidance
electrical stimulation of peripheral nerves
Lead sponsor: Mogilev Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2021-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Сomplete sensory sciatic nerve block
timeFrame: 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
measure: Сomplete motor sciatic nerve block
timeFrame: 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
measure: The need for additional pain relief during surgery
timeFrame: During the operation (start of operation - end of operation)
Secondary outcomes:
Other outcomes:
Locations:
city: Mogilev
country: Belarus
facility: Mogilev Regional Clinical Hospital
Study officials:
affiliation: Mogilev Regional Clinical Hospital
name: Valery Piacherski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: