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

Analgesic Efficacy of Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries - A Randomized Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06958120
Enrollment
50
Registered
2025-05-06
Start date
2025-06-01
Completion date
2027-02-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHD - Congenital Heart Disease

Keywords

CHD, Regional anaesthesia, Pain management

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

Interventions

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.

PROCEDUREErecto 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Pain assessmentImmediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperativelyPain was assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.

Countries

Egypt

Contacts

CONTACTReham Mahrous, MD
dr_memoo2003@hotmail.com+201006211832

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026