Regional AnesthesiaPhase 4NCT06965933
Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children
A Phase 4 study testing ESP block group and IV Lidocaine in people with Regional Anesthesia and Lidocaine Infusion, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
Testing the hypothesis that in children undergoing spinal surgery, ESP-block will increase the time to emergency anesthesia in the postoperative period compared with intravenous lidocaine infusion. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Regional Anesthesia, Lidocaine Infusion
- What is being tested?
- ESP block group and IV Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteRussia
- Study dates
- 20 May 2025to Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Elective surgery on the thoracic and lumbosacral spine. 2. Signed informed consent to participate in the study; 3. Age 3-17 years.
Who cannot join
- Contraindications to the use of local anesthetics;
- Operations on the cervical spine;
- Contraindications to performing ESPB;
- The patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Testing the hypothesis that in children undergoing spinal surgery, ESP-block will increase the time to emergency anesthesia in the postoperative period compared with intravenous lidocaine infusion.
Read the detailed description
Interventions for congenital or acquired spinal anomalies are usually voluminous and traumatic, which causes a high level of pain stimulation during the perioperative period. Thus, the problem of pain in spinal surgery is extremely important and is one of the main components of successful treatment.
Combined anesthesia using regional techniques (local anesthesia is added to general anesthesia) can be a significant alternative to performing traditional combined anesthesia with high doses of opioids (narcotic painkillers with undesirable side effects). It allows you to follow the principles of multimodal analgesia, with the possibility of rapid recovery of the patient in the postoperative period.
The use of ESPB (spinal straightening plane blockade) in vertebrology has currently been studied only in adult patients. ESPB is effective and safe for postoperative pain relief after lumbar spine surgery. ESPB can reduce the consumption of opioids (narcotic painkillers) after surgery, increase patient satisfaction, and shorten the length of hospitalization.
Currently, the use of the local anesthetic lidocaine as a medicinal agent for intravenous infusion in children, as an alternative to narcotic anesthesia, is also being actively discussed.
A large number of studies indicate the effectiveness of intravenous lidocaine infusion for perioperative anesthesia in adult patients. In pediatric practice, this technique is not widely used due to the lack of evidence base for efficacy and safety.
Intravenous infusion of lidocaine consistently improves analgesic parameters in the adult and pediatric populations in the first 24 hours, while an effective decrease in the consumption of narcotic painkillers is noted by 48 hours.
Intravenous lidocaine has demonstrated antineuropathic, antihyperalgesic and anti-inflammatory effects and is a new method. Numerous studies in adults have demonstrated the beneficial effects of intravenous lidocaine, including improved pain relief with reduced postoperative use of narcotic painkillers, earlier activation, and shorter length of stay in the intensive care unit. To date, the dose ranges studied in the pediatric population have not been associated with serious side effects, and current evidence suggests that intravenous lidocaine administration will be well tolerated.
- Conditions
- Regional Anesthesia, Lidocaine Infusion
- Being tested
- ESP block group, IV Lidocaine
- Keywords
- ESPB, Erector Spinae Plane Block, Lidocaine, Regional Anesthesia, Lidocaine infusion, Spinal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block groupProcedure or surgery
The patient will undergo an ESP blockade under the control of ultrasound during the implementation of anesthetic support. A local anesthetic will be injected into the fascial space of the muscles straightening the spine: ropivacaine 0.375%, 3 mg / kg, on both sides.
IV LidocaineDrug
During the implementation of anesthetic support, the patient will receive a constant intravenous infusion of lidocaine: a loading dose of 1.5 mg/kg/ h (1 hour), followed by an infusion of 1 mg/kg/h for 24 hours during the perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| Blockade of the plane straightening the spine (Erector Spinae Plane Block, ESPB). | Experimental | Not described Receives: Procedure: ESP block group |
| IV Lidocaine | Active comparator | Not described Receives: Drug: IV Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time before emergency pain relief (opioid).
Time before emergency pain relief (opioid).
Measured: 24 hours postoperatively
Secondary outcomes (6)
the need for opioids in the postoperative period within 24 hours
the need for opioids in the postoperative period within 24 hours (of the start of anesthesia)
Measured: 24 hours
pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)
use Wong-Baker Faces Pain Rating Scale (postoperative period)
The Wong-Baker Faces Pain Rating Scale is used for general assessment of pain intensity in adult patients and children over 3 years of age.
The scale consists of 6 faces, ranging from laughing (no pain) to crying (unbearable pain).
Each face corresponds to a certain number of points:
0 points - a happy smiling face, means no pain (No Hurt); 2 points - a slight smile on the face, means slight soreness (Hurts Little Bit); 4 points - neutral facial expression, means slight pain (Hurts Little More); 6 points - facial expression with slightly furrowed eyebrows, means average pain (Hurts Even More); 8 points - a facial expression with heavily furrowed eyebrows means severe pain (Hurts a Whole Lot); 10 points - a crying, unhappy expression means excessive unbearable pain (Hurts Worst).
Measured: 24 hours postoperatively
assessment of intraoperative analgesia quality (pulse)
pulse monitoring during surgery
Measured: during surgery
assessment of intraoperative analgesia quality (BP)
Blood pressure monitoring during surgery
Measured: during surgery
Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)
Measured: 24 hours
Complications associated with spinal straightening plane block (ESPB)
Complications: neurological, bleeding, hematoma, infection.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start20 May 2025
- Primary completion20 Apr 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxim Monastirniy, Saint Petersburg State University, Russia
- Investigators
- Maxim Sergeevich Monastirniy, Principal investigator, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965933
- Sponsor's protocol ID
- SaintPetersburgSU
- Status last verified
- May 2025
- First submitted
- 4 Apr 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: By a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children
- ClinicalTrials.gov ID
- NCT06965933
- Acronym / sponsor ID
- SaintPetersburgSU
- Conditions
- Regional Anesthesia, Lidocaine Infusion
- Keywords
- ESPB, Erector Spinae Plane Block, Lidocaine, Regional Anesthesia, Lidocaine infusion, Spinal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 May 2025 (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.
Testing the hypothesis that in children undergoing spinal surgery, ESP-block will increase the time to emergency anesthesia in the postoperative period compared with intravenous lidocaine infusion.
Detailed description
Interventions for congenital or acquired spinal anomalies are usually voluminous and traumatic, which causes a high level of pain stimulation during the perioperative period. Thus, the problem of pain in spinal surgery is extremely important and is one of the main components of successful treatment.
Combined anesthesia using regional techniques (local anesthesia is added to general anesthesia) can be a significant alternative to performing traditional combined anesthesia with high doses of opioids (narcotic painkillers with undesirable side effects). It allows you to follow the principles of multimodal analgesia, with the possibility of rapid recovery of the patient in the postoperative period.
The use of ESPB (spinal straightening plane blockade) in vertebrology has currently been studied only in adult patients. ESPB is effective and safe for postoperative pain relief after lumbar spine surgery. ESPB can reduce the consumption of opioids (narcotic painkillers) after surgery, increase patient satisfaction, and shorten the length of hospitalization.
Currently, the use of the local anesthetic lidocaine as a medicinal agent for intravenous infusion in children, as an alternative to narcotic anesthesia, is also being actively discussed.
A large number of studies indicate the effectiveness of intravenous lidocaine infusion for perioperative anesthesia in adult patients. In pediatric practice, this technique is not widely used due to the lack of evidence base for efficacy and safety.
Intravenous infusion of lidocaine consistently improves analgesic parameters in the adult and pediatric populations in the first 24 hours, while an effective decrease in the consumption of narcotic painkillers is noted by 48 hours.
Intravenous lidocaine has demonstrated antineuropathic, antihyperalgesic and anti-inflammatory effects and is a new method. Numerous studies in adults have demonstrated the beneficial effects of intravenous lidocaine, including improved pain relief with reduced postoperative use of narcotic painkillers, earlier activation, and shorter length of stay in the intensive care unit. To date, the dose ranges studied in the pediatric population have not been associated with serious side effects, and current evidence suggests that intravenous lidocaine administration will be well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blockade of the plane straightening the spine (Erector Spinae Plane Block, ESPB). | Experimental | Procedure: ESP block group |
| IV Lidocaine | Active comparator | Drug: IV Lidocaine |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Elective surgery on the thoracic and lumbosacral spine. 2. Signed informed consent to participate in the study; 3. Age 3-17 years.
Key exclusion criteria (4 listed)
- Contraindications to the use of local anesthetics;
- Operations on the cervical spine;
- Contraindications to performing ESPB;
- The patient's refusal to participate in the study.
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 |
|---|---|---|
| ESP block groupThe patient will undergo an ESP blockade under the control of ultrasound during the implementation of anesthetic support. A local anesthetic will be injected into the fascial space of the muscles straightening the spine: ropivacaine 0.375%, 3 mg / kg, on both sides. | Procedure or surgery | Blockade of the plane straightening the spine (Erector Spinae Plane Block, ESPB). |
| IV LidocaineDuring the implementation of anesthetic support, the patient will receive a constant intravenous infusion of lidocaine: a loading dose of 1.5 mg/kg/ h (1 hour), followed by an infusion of 1 mg/kg/h for 24 hours during the perioperative period. | Drug | IV Lidocaine |
Primary outcome
Time before emergency pain relief (opioid).
Time frame: 24 hours postoperatively
Time before emergency pain relief (opioid).
6 secondary outcomes
the need for opioids in the postoperative period within 24 hours
Time frame: 24 hours
pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)
Time frame: 24 hours postoperatively
assessment of intraoperative analgesia quality (pulse)
Time frame: during surgery
assessment of intraoperative analgesia quality (BP)
Time frame: during surgery
Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)
Time frame: 24 hours
Complications associated with spinal straightening plane block (ESPB)
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided. By a reasonable request
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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.
Maxim Sergeevich Monastirniy principal investigator
Saint Petersburg State University, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESP block group and IV Lidocaine in people with Regional Anesthesia and Lidocaine Infusion, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. 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 Russia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time before emergency pain relief (opioid). (time frame: 24 hours postoperatively). 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 30 Apr 2026.