Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy

NCT06984276 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2024-09-30

Last updated

2025-05-30

Condition(s) studied

UltrasoundPectoral Nerve BlockTransverse Thoracic Plane BlockPediatric PatientsCorrective Cardiac SurgeriesCardiopulmonary BypassMedian Sternotomy

Investigational drug(s) / intervention(s)

ControlPectoral nerves (PECS)Transversus thoracic muscle plane block (TTPB)

Control: Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation.

Pectoral nerves (PECS): This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus ultrasound guided bilateral pectoral nerves (PECS) Block which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .

Transversus thoracic muscle plane block (TTPB): This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus Ultrasound guided bilateral transversus thoracic muscle plane block (TTPB) which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .

Study summary

This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries.

Eligibility

Sex

ALL

Min age

6 Months

Max age

7 Years

Healthy volunteers

Inclusion Criteria: * Age: 6 months - 7 years. * Gender: both sexs . * Risk Adjustment for Congenital Heart Surgery (RACHS) II and III. * Patients undergoing cardiac surgeries requiring cardiopulmonary bypass with midline sternotomy incision. Exclusion Criteria: * Patients whose parents or legal guardians refuse to participate. * Preoperative mechanical ventilation. * Patients in coma, mental retardation, neurological disease, or on drugs affecting the behaviour. * Preoperative inotropic drug infusion. * (Bleeding disorders (drug induced i.e., coumadin; or genetic e.g. hemophilia; or acquired e.g. disseminated intravascular coagulation \[DIC\]), coagulopathy: Partial Thromboplastin Time (PTT) \> 40 seconds, International Normalized Ratio (INR) \> 1.4, platelet count \< 100x10⁹. * Known or suspected allergy to any of the studied drugs. * Severe pulmonary hypertension (mean resting blood pressure in pulmonary arteries is above 70mmHg). * Cardiopulmonary bypass time more than 90 minutes. * local infection. * Significant Renal impairment (creatinine more than 1.2mg/dl) * Aortic cross-clamp time more than 45 minutes. * Total time from induction till intensive Care Unit (ICU) transfer more than 4 hours and 30 mins.

Primary outcome measure(s)

The total dose of intraoperative fentanyl — Intraoperatively
The total dose of intraoperative fentanyl will be recorded

Trial sites (1)

Facility	City	Region	Status
Cairo University	Cairo	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06984276 on ClinicalTrials.gov ↗ ← All trials in Egypt