Deep Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Patients Undergoing Primary Repair of Septal Defects Via Median Sternotomy

NCT06873906 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: FMASU MD124/2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we are aiming to compare the Erector Spinae Plane Block and the Deep Parasternal intercostal plane block as regard to their technique, application and outcome in order to describe the most suitable method for pediatric cardiac patients undergoing primary repair of septal defects The primary outcome of this study will be the time of the first request for postoperative analgesics by FLACC pain scale more than 4 The secondary outcomes will be the total postoperative analgesic consumption, time for extubation, the incidence of nausea and vomiting, hemodynamic instability, onset of ambulation and any other complications on the first day after surgery Participants will be enrolled in this double-blinded randomly allocated using computer-based randomization into three groups. Group 1 will receive bilateral deep parasternal intercostal plane block. Group 2 will receive bilateral erector spinae plane block. Group 3 will receive conventional analgesic regimen without having a regional block

Conditions

Septal Defect

Keywords

septal defect; acyanotic heart disease; median sternotomy; deep parasternal intercostal plane block; erector spinae plane block; eras

Outcome Measures

Primary Outcomes (1)

• Time of the first request for postoperative analgesics

  The time of the first request for postoperative analgesics by Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale more than 4. Patients will be assessed at 0, ½, 1, 2, 4, 6, 8, 12, 24 hours.

  24 hours

Secondary Outcomes (6)

• Total postoperative analgesic consumption.

  24 hours

• Time for extubation

  24 hours

• Incidence of nausea

  24 hours

• Hemodynamic instability

  24 hours

• Onset of ambulation

  24 hours

Study Arms (3)

Deep Parasternal Intercostal Plane Block

ACTIVE COMPARATOR

Patients will receive bilateral deep parasternal intercostal plane block.

Procedure: Deep Parasternal intercostal plane block

Erector Spinae plane block

ACTIVE COMPARATOR

Patients will receive bilateral erector spinae plane block

Procedure: Erector Spinae Plane Block

conventional analgesic regimen

ACTIVE COMPARATOR

patients will receive conventional analgesic regimen

Drug: conventional analgesic regimen

Interventions

Deep Parasternal intercostal plane block PROCEDURE

Patients will receive bilateral deep parasternal plane block using, 1mg/kg of 0.25% bupivacaine on each side under ultrasound guidance. The total dose of bupivacaine amounting to 2 mg/kg.

Deep Parasternal Intercostal Plane Block

Erector Spinae Plane Block PROCEDURE

Patients will receive bilateral erector spinae plane block using, 1 mg/kg of 0.25% bupivacaine will be administered on each side under ultrasound guidance. The total dose of bupivacaine amounted to 2 mg/kg

Erector Spinae plane block

conventional analgesic regimen DRUG

Anesthesia will be induced with IV ketamine, 2 mg/kg, fentanyl, 2 µg/kg, and rocuronium 0.9 mg/kg, administered to facilitate endotracheal intubation. Maintenance of anesthesia will be achieved by isoflurane at an end tidal concentration of 1-1.5% in FiO2 of 0.5, intravenous fentanyl at a dose of 1 µg/kg in incremental dosage, and intravenous rocuronium 0.15 mg/kg administration according to nerve stimulator.

conventional analgesic regimen

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients with acyanotic heart disease
• Patients with septal defect undergoing primary repair
• ASA Ⅰ and Ⅱ

You may not qualify if:

• Patient's guardian refusal of procedure or participation in the study.
• Patients with hemodynamic instability
• Preexisting infection at the block site
• Allergy to local anesthetics
• Psychiatric illness
• Abnormal coagulation profile
• Preoperative ejection fraction less than 35%
• Recurrent ventricular arrhythmias
• Emergency Surgery
• Redo surgeries

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Heart Septal Defects

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sarah A. H. Bakr, Ms degree of Anesthesia

CONTACT

[202] 01062638487; sarahhanee@med.asu.edu.eg

Amin M Alansary, MD of Anesthesia

CONTACT

[202] 01007962192; aminalansary@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 13, 2025
• Study Start: March 20, 2025
• Primary Completion: March 20, 2026
• Study Completion: April 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)