Sciatic Nerve Blockade by Subgluteal Access 12.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves (Influence of the Sciatic Nerve Blockade on the Effectiveness of Small Doses of Local Anesthetic.).

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 90 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Nerve Block, Efficiency, Sciatic Nerve, Ultrasonography, Minimum Effective Dose

Being tested

Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves 12.5 ml 1% lidocaine, sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator 12.5 ml 1% lidocaine

Keywords

sciatic nerve block, ultrasound guidance, electrical stimulation of peripheral nerves, lidocaine, Аnesthetics Local, Minimum Effective Dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves 12.5 ml 1% lidocaineProcedure or surgery

  Also called Anesthesia for lower limb surgery

  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 (12.5 ml 1% lidocaine).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 12.5 ml 1% lidocaineProcedure or surgery

  Also called Anesthesia for lower limb surgery

  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 (12.5 ml 1% lidocaine) 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Сomplete sensory sciatic nerve block

   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.

   Measured: 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

2. Сomplete motor sciatic nerve block

   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

   Measured: 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

3. The need for additional pain relief during surgery

   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.

   Measured: During the operation (start of operation - end of operation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Jan 2022
2. Study start1 Feb 2022
3. Primary completion16 May 2022
4. Study completion16 May 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Nerve BlockStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.