Nerve BlockNCT05209711
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)
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 EPN. 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, Femoral Nerve
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Feb 2022to 31 Oct 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;
Show all 10Show fewer
- 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.
Lidziya Muzyka contact
Belarus1 site, 1 recruiting
- Recruiting
Mogilev Regional Clinical Hospital
Mogilev, 212026
Valery Piacherski, Ph.D., +375445378157, pechersky.v@yandex.ru
Lidziya Muzyka, lida.muzyka@yandex.by
About this study
Official title: Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves
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.
- Conditions
- Nerve Block, Efficiency, Femoral Nerve, Ultrasonography, Minimum Effective Dose
- Being tested
- Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaine, Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine
- Keywords
- femoral 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.
Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaineProcedure or 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 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, and a positive muscular response . Subsequently, the introduction of LA solution was initiated (7.5 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 sciatic nerve block is performed.
Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaineProcedure or surgery
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 (7.5 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 sciatic nerve block is performed.
| Study group | Role | What they receive |
|---|---|---|
| FN blockade under ultrasound control with a peripheral nerve stimulator 7.5 ml 1% lidocaine | Other | Patients undergoing surgery on the shin, ankle or foot Receives: Procedure: Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaine |
| FN blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine | Other | Patients undergoing surgery on the shin, ankle or foot Receives: Procedure: Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Сomplete sensory femoral nerve block
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.
Measured: 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 (1)
Сomplete motor femoral 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Feb 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
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 (estimated)
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 HospitalLidziya Muzyka, Principal investigator, Mogilev Regional Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209711
- Sponsor's protocol ID
- 7.5ml femoral nerve
- Status last verified
- Aug 2022
- First submitted
- 13 Jan 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves
- ClinicalTrials.gov ID
- NCT05209711
- Acronym / sponsor ID
- 7.5ml femoral nerve
- Conditions
- Nerve Block, Efficiency, Femoral Nerve, Ultrasonography, Minimum Effective Dose
- Keywords
- femoral nerve block, ultrasound guidance, electrical stimulation of peripheral nerves
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mogilev Regional Clinical HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 27 Jan 2022 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FN blockade under ultrasound control with a peripheral nerve stimulator 7.5 ml 1% lidocaine | Other | Procedure: Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocainePatients undergoing surgery on the shin, ankle or foot |
| FN blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine | Other | Procedure: Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocainePatients undergoing surgery on the 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 |
|---|---|---|
| Femoral nerve block under ultrasound control with a electrostimulator peripheral nerves 7.5 ml 1% lidocaineFollowing 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 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, and a positive muscular response . Subsequently, the introduction of LA solution was initiated (7.5 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 sciatic nerve block is performed. | Procedure or surgery | FN blockade under ultrasound control with a peripheral nerve stimulator 7.5 ml 1% lidocaine |
| Femoral nerve blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaineUnder 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 (7.5 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 sciatic nerve block is performed. | Procedure or surgery | FN blockade under ultrasound control without a peripheral nerve stimulator 7.5 ml 1% lidocaine |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Lidziya Muzyka contact
Valery Piacherski, Ph.D. principal investigator
Mogilev Regional Clinical Hospital
Lidziya Muzyka 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: status not confirmed, as of the sponsor's last update on 26 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valery Piacherski, Ph.D. (+375445378157, pechersky.v@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). 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 26 Aug 2022.