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

Not Applicable

• Conditions: Anesthesia
• Interventions: Procedure: Nerve block

• Registration Number: NCT05132946
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-01
• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-12
• Last Update Submitted: 2021-11-12
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The number of times for usage of fentanyl in postoperative period	in the first 12 hours.

Trial Locations

Locations (1)

Samar Soliman; 🇪🇬 Cairo, Nasr City, Egypt