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

Not Applicable

Recruiting

• Conditions: Ultrasound; Pectoral Nerve Block; Corrective Cardiac Surgeries; Transverse Thoracic Plane Block; Pediatric Patients; Cardiopulmonary Bypass; Median Sternotomy
• Interventions: Other: Transversus thoracic muscle plane block (TTPB); Other: Pectoral nerves (PECS); Drug: Control

• Registration Number: NCT06984276
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2024-09-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Study First Posted: 2025-05-22
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus thoracic muscle plane block group	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 .
Pectoral nerves group	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 .
Control group	Control	Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation.

Primary Outcome Measures

Name	Time	Method
The total dose of intraoperative fentanyl	Intraoperatively	The total dose of intraoperative fentanyl will be recorded

Secondary Outcome Measures

Name	Time	Method
Degree of pain	12 hours postoperatively	Pain will be assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score immediately after admission to intensive care unit (ICU) then at 60 min, 2 hours, 4hours, 8hours and 12 hours postoperatively.; If the patient FLACC score equal or more than 4, patient will receive Fentanyl I.V 1 mic /kg .
Heart rate	12 hours postoperatively	Heart rate (HR) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours
Mean arterial pressure	12 hours postoperatively	Mean arterial pressure (MAP) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours
Total consumption of Fentanyl	12 hours postoperatively	Total consumption of Fentanyl during the 1st 12 hours postoperatively will be recorded
Time to 1st rescue analgesia	12 hours postoperatively	Time to 1st rescue analgesia post operatively which will be defined to be the elapsed time between giving the block and a patient FLACC score equal or more than 4.
Time of Extubation	12 hours postoperatively	Time of Extubation will be recorded
The incidence of opioid complications	12 hours postoperatively	The incidence of opioid complications like postoperative nausea and vomiting (PONV), hematoma formation, itching will be recorded
The incidence of Local anatectic toxicity	12 hours postoperatively	The incidence of Local anatectic toxicity like neurologic symptoms (seizures, and ultimately neurologic depression with respiratory arrest, coma, or both) and Cardiovascular symptoms may include an hypertensive , tachycardia, cardiac depression with bradycardia, myocardial depression, conduction block, asystole, and cardiac arrest.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt