RecruitingNot ApplicableNCT06984276

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

Efficacy Of 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: A Randomized Controlled Trial.

Sponsor

Cairo University

Enrollment

81 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Ultrasound Cardiopulmonary Bypass Pediatric Patients Pectoral Nerve Block Transverse Thoracic Plane Block Corrective Cardiac Surgeries Median Sternotomy

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

Min Age: 6 MonthsMax Age: 7 Years

Inclusion Criteria4

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 Criteria12

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.

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Interventions

DRUGControl

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

OTHERPectoral 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 .

OTHERTransversus 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 .