Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block

NCT06958120 | Not Yet Recruiting

• 1 other identifier: BLocks in pediatric cardiac op
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Group (A): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side3. Group (B): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .

Conditions

CHD - Congenital Heart Disease

Keywords

CHD; Regional anaesthesia; Pain management

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  Pain was assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.

  Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively

Study Arms (2)

Superficial parasternal intercostal Plane block group

EXPERIMENTAL

This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block

Procedure: superficial parasternal intercostal Plane block

Erecto-Spinea plane block group

EXPERIMENTAL

This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral Erecto-Spinea plane block

Procedure: Erecto spinea plane block

Interventions

superficial parasternal intercostal Plane block PROCEDURE

A high-frequency linear transducer was used to guide the insertion of a needle 2 cm lateral to the sternum. After identifying key anatomical structures, the needle was advanced in-plane into the pectointercostal fascial plane between the pectoralis major and internal intercostal muscle. Correct placement was confirmed with a saline injection, and then a local anesthetic (0.4 ml/kg of a 1:1 mix of bupivacaine 0.25% and lidocaine 1%) was injected bilaterally at the second and fourth ribs.

Superficial parasternal intercostal Plane block group

Erecto spinea plane block PROCEDURE

Using ultrasound, a needle is inserted near the T5 vertebra into the plane beneath the erector spinae muscle. After confirming correct positioning with saline, a local anesthetic mixture is injected in the fascial plane.

Erecto-Spinea plane block group

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• RACHS-1: Categories 1, 2 and 3
• Patients undergoing corrective cardiac surgeries with midline sternotomy incision.
• Redo surgeries.

You may not qualify if:

• Patients whose parents or legal guardians refuse to participate.
• Preoperative mechanical ventilation.
• Preoperative inotropic drug infusion.
• Coagulopathy.
• Allergy to any of the studied drugs.
• Severe pulmonary hypertension (\> 70 mmHg).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abu Al reesh hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Agnosia

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 6, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2026
• Access Criteria: Any

Locations

EG (1)