Clinical trial NCT06965933: Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children
Official title: Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Regional Anesthesia
Lidocaine Infusion
Keywords: ESPB
Erector Spinae Plane Block
Lidocaine
Regional Anesthesia
Lidocaine infusion
Spinal Surgery
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time before emergency pain relief (opioid).
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: the need for opioids in the postoperative period within 24 hours
timeFrame: 24 hours
measure: pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)
timeFrame: 24 hours postoperatively
measure: assessment of intraoperative analgesia quality (pulse)
timeFrame: during surgery
measure: assessment of intraoperative analgesia quality (BP)
timeFrame: during surgery
measure: Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)
timeFrame: 24 hours
measure: Complications associated with spinal straightening plane block (ESPB)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: SaintPetersburgSU
Study officials:
affiliation: Saint Petersburg State University, Russia
name: Maxim Sergeevich Monastirniy
role: PRINCIPAL_INVESTIGATOR
References: