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NCT Number: NCT05209490

Ultrasound-guided Femoral Nerve Block Without Electrical Stimulation of Peripheral Nerves

There is little work comparing the effectiveness of a femoral nerve block performed only under US guidance or US plus electrical stimulation of the peripheral nerve (EPN). The authors have shown the same effectiveness of these techniques(1).But the effectiveness of the blockade of the femoral nerve (complete blockade) performed in different ways turned out to be low valve: 71.7% for ultrasound in combination with electrical stimulation versus 69% for only ultrasound guidance.

Research hypothesis: the blockade of the femoral nerve 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 Femoral 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

Femoral nerve blockade under ultrasound control with a peripheral nerve stimulator

Procedure

Following the ultrasound visualization of the femoral 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 sciatic femoral nerve block is performed.

femoral nerve blockade under ultrasound control without a peripheral nerve stimulator

Procedure

Under ultrasound visualization guidance, the needle owas positioned at the femoral 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 sciatic nerve block is performed.

Primary outcomes

  1. Сomplete sensory femoral nerve block

    Time frame: 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

    The stimulus of the needle prick was applied to check the sensory block of thefemoral nerve. 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.

Secondary outcomes

  1. Сomplete motor femoral nerve block

    Time frame: 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

    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.

Other outcomes

  1. 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

Femoral Nerve Block: Comparison of the Effectiveness of Ultrasound Control Versus Ultrasound Control With Electrical Stimulation of Peripheral Nerves

Acronym: USvsUSEPN

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Aug 26, 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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