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Completed

NCT Number: NCT05054881

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

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.

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Key information

Conditions

Nerve Block Efficiency Sciatic Nerve Ultrasonography

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mogilev Regional Clinical Hospital

Mogilev, 212026, Belarus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sciatic nerve blockade under ultrasound control with a peripheral nerve stimulator

Other

Following the ultrasound visualization of the sciatic 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.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.

sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator

Other

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 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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Mogilev Regional Clinical Hospital

Other Gov

Registry information

Official study title

Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation in Lower Limb Surgeries

Acronym: EPBwEPN

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2021
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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