Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair

Ain Shams University

Status: Unknown

Conditions: Anesthesia

Treatments: Procedure: Nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT05132946

FAMSU R 167/2021

Details and patient eligibility

About

The study will include 40 patients who fulfil all the points in the inclusion and exclusion criteria will be randomized into two equal groups, each consisting of 20 patients, namely group (B) and group (C).

• Group (B): will receive erector spinae plane block.
• Group (C): will not receive any block. Postoperative pain score will be assessed using the FLACC scale or Face, Legs, Activity, Cry, Consolability scale immediately after extubation and at 1, 2, 4, 6, 8, 12, 18, and 24 hours. Routine postoperative analgesia in the form of intravenous paracetamol 7.5 mg/kg/6 hours will be given to all patients (the first dose is given after skin closure). Rescue analgesia in the form of 1 ug/kg fentanyl intravenously for patients if FLACC scale > 4, and the time for the first rescue analgesic administration will be recorded.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All pediatric patients presented for aortic coarctation repair via left thoracotomy.

Exclusion criteria

Hypersensitivity to local anesthetic.

• Mental or neurologic disorders.
• Preoperative critically ill patients.
• Parents or legal guardian refusal.
• Infection at the site of injection.
• Any liver disease.
• Any coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Group (B): will receive erector spinae plane block.

Active Comparator group

Description:

unilateral ultrasound-guided erector spinae plane block using bupivacaine 0.25% (on the left side) with total volume 0.5 ml/kg and a maximum dose of 2 mg/kg of bupivacaine in erector spinae plane block group patients

Treatment:

Procedure: Nerve block

• Group (C): will not receive any block.

No Intervention group