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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132946
• Other study ID #: FAMSU R 167/2021
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: November 2021
• Source: Ain Shams University
• Contact: Samar MD Soliman, Lecturer
• Phone: 01006236494
• Email: dr_sm.md[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 10, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Aortic Coarctation

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Samar Soliman	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of times for usage of fentanyl in postoperative period		in the first 12 hours.