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

Cairo University (CU)

Status: Enrolling

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

Treatments: Other: Pectoral nerves (PECS); Other: Transversus thoracic muscle plane block (TTPB); Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06984276

MD-263-2024

Details and patient eligibility

About

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.

Full description

Good perioperative analgesia in cardiac surgical patients helps early recovery, ambulation, and early discharge from the Intensive Care Unit (ICU). Traditional use of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids associated with adverse effect commonly used for pain control postoperative.

The transversus thoracic muscle plane block (TTPB) is a recently advised regional anesthesia method that provides analgesia to the anterior chest wall and was initially introduced by Ueshima et al. in 2015 .

The pectoral nerves (PECS) block has evolved to be two different types: PECS I and PECS II. In PECS I block, anesthetic is injected in the interfacial plane between the pectoralis major and minor muscles at the 3rd rib, blocking the lateral and medial pectoral nerves. The PECS II block, which was also developed by Blanco in 2012.

The PECS block has been well established for its use in breast surgery for the adult population. , However, there has been a recent push in the last couple of years to find more about other uses for these types of blocks, especially in cardiac surgeries.

Enrollment: 81 estimated patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 3 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Control

Pectoral nerves group

Experimental group

Description:

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 .

Treatment:

Other: Pectoral nerves (PECS)

Transversus thoracic muscle plane block group

Experimental group

Description:

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 .

Treatment:

Other: Transversus thoracic muscle plane block (TTPB)