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 | Recruiting

• 1 other identifier: MD-263-2024
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The total dose of intraoperative fentanyl

  The total dose of intraoperative fentanyl will be recorded

  Intraoperatively

Secondary Outcomes (8)

• Degree of pain

  12 hours postoperatively

• Heart rate

  12 hours postoperatively

• Mean arterial pressure

  12 hours postoperatively

• Total consumption of Fentanyl

  12 hours postoperatively

• Time to 1st rescue analgesia

  12 hours postoperatively

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Drug: Control

Pectoral nerves group

EXPERIMENTAL

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 .

Other: Pectoral nerves (PECS)

Transversus thoracic muscle plane block group

EXPERIMENTAL

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 .

Other: Transversus thoracic muscle plane block (TTPB)

Interventions

Control DRUG

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

Also known as: Fentanyl

Control group

Pectoral nerves (PECS) 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 .

Also known as: Bupivacaine 0.25% and lidocaine 1%

Pectoral nerves group

Transversus thoracic muscle plane block (TTPB) 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 .

Also known as: Bupivacaine 0.25% and lidocaine 1%)

Transversus thoracic muscle plane block group

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Fentanyl; Bupivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mai M Elfiky, Master

CONTACT

00201110404608; maielfiky45@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Surgical ICU and Pain Management, Cairo University Hospitals.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 22, 2025
• Study Start: September 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)