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

NCT ID: NCT06984276

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DRUG

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

Pectoral nerves group

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 .

Group Type: EXPERIMENTAL

Pectoral nerves (PECS)

Intervention Type: OTHER

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 group

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 .

Group Type: EXPERIMENTAL

Transversus thoracic muscle plane block (TTPB)

Intervention Type: OTHER

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 .

Interventions

Control

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

Intervention Type: DRUG

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 .

Intervention Type: OTHER

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 .

Intervention Type: OTHER

Other Intervention Names

Fentanyl; Bupivacaine 0.25% and lidocaine 1%; Bupivacaine 0.25% and lidocaine 1%)

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Mohamed Mahmoud Elfiky

Assistant Lecturer of Anesthesia, Surgical ICU and Pain Management, Cairo University Hospitals.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mai M Elfiky, Master

Role: CONTACT

maielfiky45@gmail.com

00201110404608

Facility Contacts

Mai M Elfiky, Master

Role: primary

maielfiky45@gmail.com

00201110404608

Other Identifiers

MD-263-2024

Identifier Type: -

Identifier Source: org_study_id