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

NCT06965933 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: SaintPetersburgSU
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Lidocaine Infusion

Keywords

ESPB; Erector Spinae Plane Block; Lidocaine; Regional Anesthesia; Lidocaine infusion; Spinal Surgery

Outcome Measures

Primary Outcomes (1)

• Time before emergency pain relief (opioid).

  Time before emergency pain relief (opioid).

  24 hours postoperatively

Secondary Outcomes (6)

• the need for opioids in the postoperative period within 24 hours

  24 hours

• pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)

  24 hours postoperatively

• assessment of intraoperative analgesia quality (pulse)

  during surgery

• assessment of intraoperative analgesia quality (BP)

  during surgery

• Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)

  24 hours

Study Arms (2)

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

EXPERIMENTAL

Procedure: ESP block group

IV Lidocaine

ACTIVE COMPARATOR

Drug: IV Lidocaine

Interventions

IV Lidocaine 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.

IV Lidocaine

ESP block group 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.

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

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

SaintPetersburgSU

Saint Petersburg, Sankt-Peterburg, 190121, Russia

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Maxim Sergeevich Monastirniy

  Saint Petersburg State University, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist-Intensivist, Research Physician

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 11, 2025
• Study Start: May 20, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-05

Locations

RU (1)