Nerve BlockEPBwEPNNCT05054881
Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation
A study of Nerve Block and Efficiency, run by Mogilev Regional Clinical Hospital at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nerve Block, Efficiency, Sciatic Nerve
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelarus
- Study dates
- 4 Apr 2022to 13 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- indication requiring anesthesia maintenance;
- patient's written consent about the type of anesthesia and possible complications of regional anesthesia
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation in Lower Limb Surgeries
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.
- Conditions
- Nerve Block, Efficiency, Sciatic Nerve, Ultrasonography
- Being tested
- sciatic nerve blockade under ultrasound control with a peripheral nerve stimulator, sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator
- Keywords
- sciatic nerve block, ultrasound guidance, electrical stimulation of peripheral nerves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sciatic nerve blockade under ultrasound control with a peripheral nerve stimulatorOther
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 stimulatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves | Other | Patients undergoing surgery on the knee, shin, ankle or foot Receives: Other: sciatic nerve blockade under ultrasound control with a peripheral nerve stimulator |
| Sciatic nerve block under ultrasound control without a electrostimulator peripheral nerves | Other | Patients undergoing surgery on the knee, shin, ankle or foot Receives: Other: sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted23 Sep 2021
- Study start4 Apr 2022
- Primary completion13 Jul 2022
- Study completion13 Jul 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mogilev Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valery Piacherski, Ph.D., Mogilev Regional Clinical Hospital
- Investigators
- Valery Piacherski, Ph.D., Principal investigator, Mogilev Regional Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054881
- Sponsor's protocol ID
- 4
- Acronym
- EPBwEPN
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact us: Valery Piacherski, Ph.D.; pechersky.v@yandex.ru
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation in Lower Limb Surgeries
- ClinicalTrials.gov ID
- NCT05054881
- Acronym / sponsor ID
- EPBwEPN / 4
- Conditions
- Nerve Block, Efficiency, Sciatic Nerve, Ultrasonography
- Keywords
- sciatic nerve block, ultrasound guidance, electrical stimulation of peripheral nerves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mogilev Regional Clinical HospitalOther government
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves | Other | Other: sciatic nerve blockade under ultrasound control with a peripheral nerve stimulatorPatients undergoing surgery on the knee, shin, ankle or foot |
| Sciatic nerve block under ultrasound control without a electrostimulator peripheral nerves | Other | Other: sciatic nerve blockade under ultrasound control without a peripheral nerve stimulatorPatients undergoing surgery on the knee, shin, ankle or foot |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication requiring anesthesia maintenance;
- patient's written consent about the type of anesthesia and possible complications of regional anesthesia
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sciatic nerve blockade under ultrasound control with a peripheral nerve stimulatorFollowing 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. | Other | Sciatic nerve block under ultrasound control with a electrostimulator peripheral nerves |
| sciatic nerve blockade under ultrasound control without a peripheral nerve stimulatorUnder 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. | Other | Sciatic nerve block under ultrasound control without a electrostimulator peripheral nerves |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Yes. Contact us: Valery Piacherski, Ph.D.; pechersky.v@yandex.ru
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valery Piacherski, Ph.D. principal investigator
Mogilev Regional Clinical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Nerve Block and Efficiency, run by Mogilev Regional Clinical Hospital at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.