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NCT Number: NCT06958120

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

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 .

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Key information

Conditions

CHD - Congenital Heart Disease Agnosia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Preoperative assessment Premedication Monitoring General Anesthesia induction Arterial and Venous cannulation Fentanyl Infusion Giving block according to the group Intra operative recording of hemodynamics Post operative pain assessment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain assessment

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

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Analgesic Efficacy of Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries - A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 6, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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