Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block

NCT ID: NCT06958120

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-02-28

Brief Summary

Group (A): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side3.

Group (B): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .

Detailed Description

Preoperative assessment Premedication Monitoring General Anesthesia induction Arterial and Venous cannulation Fentanyl Infusion Giving block according to the group Intra operative recording of hemodynamics Post operative pain assessment

Conditions

CHD - Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Superficial parasternal intercostal Plane block group

This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block

Group Type: EXPERIMENTAL

superficial parasternal intercostal Plane block

Intervention Type: PROCEDURE

A high-frequency linear transducer was used to guide the insertion of a needle 2 cm lateral to the sternum. After identifying key anatomical structures, the needle was advanced in-plane into the pectointercostal fascial plane between the pectoralis major and internal intercostal muscle. Correct placement was confirmed with a saline injection, and then a local anesthetic (0.4 ml/kg of a 1:1 mix of bupivacaine 0.25% and lidocaine 1%) was injected bilaterally at the second and fourth ribs.

Erecto-Spinea plane block group

This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral Erecto-Spinea plane block

Group Type: EXPERIMENTAL

Erecto spinea plane block

Intervention Type: PROCEDURE

Using ultrasound, a needle is inserted near the T5 vertebra into the plane beneath the erector spinae muscle. After confirming correct positioning with saline, a local anesthetic mixture is injected in the fascial plane.

Interventions

superficial parasternal intercostal Plane block

A high-frequency linear transducer was used to guide the insertion of a needle 2 cm lateral to the sternum. After identifying key anatomical structures, the needle was advanced in-plane into the pectointercostal fascial plane between the pectoralis major and internal intercostal muscle. Correct placement was confirmed with a saline injection, and then a local anesthetic (0.4 ml/kg of a 1:1 mix of bupivacaine 0.25% and lidocaine 1%) was injected bilaterally at the second and fourth ribs.

Intervention Type: PROCEDURE

Erecto spinea plane block

Using ultrasound, a needle is inserted near the T5 vertebra into the plane beneath the erector spinae muscle. After confirming correct positioning with saline, a local anesthetic mixture is injected in the fascial plane.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• RACHS-1: Categories 1, 2 and 3
• Patients undergoing corrective cardiac surgeries with midline sternotomy incision.
• Redo surgeries.

Exclusion Criteria

• Patients whose parents or legal guardians refuse to participate.
• Preoperative mechanical ventilation.
• Preoperative inotropic drug infusion.
• Coagulopathy.
• Allergy to any of the studied drugs.
• Severe pulmonary hypertension (> 70 mmHg).

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reham Mahrous

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abu Al reesh hospital

Cairo, , Egypt

Countries

Egypt

Facility Contacts

Cairo University hospitals

Role: primary

website@kasralainy.edu.eg

+20223643524

Other Identifiers

BLocks in pediatric cardiac op

Identifier Type: -

Identifier Source: org_study_id