Clinical trial NCT05209711: Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves (Influence of the Femoral Nerve Blockade on the Effectiveness of Small Doses of Local Anesthetic.). (EPBwEPN)
Official title: Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Efficiency
Femoral Nerve
Ultrasonography
Minimum Effective Dose
Keywords: femoral nerve block
ultrasound guidance
electrical stimulation of peripheral nerves
Lead sponsor: Mogilev Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-27
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 EPN. The most effective methods are with the use of ultrasound control. Until now, the effectiveness of the femoral nerve blockade, performed only under ultrasound control without EPN, in comparison with the blockade of the femoral nerve performed under ultrasound control with EPN, has not been established.

There is no data on how the effectiveness of the blockade of the femoral 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 femoral nerve (7.5 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.


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 femoral nerve block
timeFrame: 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:
measure: Сomplete motor femoral nerve block
timeFrame: 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:
measure: The need for additional pain relief during surgery
timeFrame: During the operation (start of operation - end of operation)
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
affiliation: Mogilev Regional Clinical Hospital
name: Lidziya Muzyka
role: PRINCIPAL_INVESTIGATOR
References: