Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children

NCT ID: NCT06965933

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Blockade of the plane straightening the spine (Erector Spinae Plane Block, ESPB).

Group Type: EXPERIMENTAL

ESP block group

Intervention Type: PROCEDURE

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 Lidocaine

Group Type: ACTIVE_COMPARATOR

IV Lidocaine

Intervention Type: DRUG

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.

Interventions

ESP block group

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.

Intervention Type: PROCEDURE

IV Lidocaine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Elective surgery on the thoracic and lumbosacral spine. 2. Signed informed consent to participate in the study; 3. Age 3-17 years.

Exclusion Criteria

1. Contraindications to the use of local anesthetics;

2. Operations on the cervical spine;

3. Contraindications to performing ESPB;

4. The patient's refusal to participate in the study.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Petersburg State University, Russia

OTHER

Sponsor Role: lead

Responsible Party

Maxim Monastirniy

Anesthesiologist-Intensivist, Research Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maxim Sergeevich Monastirniy

Role: PRINCIPAL_INVESTIGATOR

Saint Petersburg State University, Russia

Locations

SaintPetersburgSU

Saint Petersburg, Sankt-Peterburg, Russia

Countries

Russia

Central Contacts

Maxim Sergeevich Monastirniy

Role: CONTACT

doctor.maksimsergeevich@gmail.com

+79818870151

Facility Contacts

Maxim Sergeevich Monastyrnyi, Medicinae Doctor (M.D.)

Role: primary

doctor.maksimsergeevich@gmail.com

+79818870151

Other Identifiers

SaintPetersburgSU

Identifier Type: -

Identifier Source: org_study_id