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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06965933
Enrollment
68
Registered
2025-05-11
Start date
2025-05-31
Completion date
2026-05-31
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Anesthesia, Lidocaine Infusion

Keywords

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

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.

Interventions

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.

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.

Sponsors

Saint Petersburg State University, Russia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time before emergency pain relief (opioid).24 hours postoperativelyTime before emergency pain relief (opioid).

Secondary

MeasureTime frameDescription
pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)24 hours postoperativelyuse 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).
assessment of intraoperative analgesia quality (pulse)during surgerypulse monitoring during surgery
the need for opioids in the postoperative period within 24 hours24 hoursthe need for opioids in the postoperative period within 24 hours (of the start of anesthesia)
Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)24 hours
Complications associated with spinal straightening plane block (ESPB)24 hoursComplications: neurological, bleeding, hematoma, infection.
assessment of intraoperative analgesia quality (BP)during surgeryBlood pressure monitoring during surgery

Countries

Russia

Contacts

Primary ContactMaxim Sergeevich Monastirniy
doctor.maksimsergeevich@gmail.com+79818870151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026