A Combination of Intrathecal Fentanyl and Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery.

NANot yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 20, 2025

Primary Completion Date

October 10, 2025

Study Completion Date

October 10, 2025

Conditions
Postoperative PainPediatric Open Heart Surgery
Interventions
PROCEDURE

PIFB group

A pecto-intercostal-fascial plane block (PIFB) will be performed bilaterally in a supine position after induction of anaesthesia. The in-plane needle approach will be applied under the guidance of a high-frequency Hockey Stick Linear-Array US transducer probe (SONOSITE M-TURBO). Under strict aseptic precautions, the transducer will be placed 1-2 cm lateral to and parallel to the sternum to count the ribs from the second to the sixth rib. A 22-gauge, 50-mm short bevel echogenic needle will be advanced in a caudal-to-cranial direction until the tip of the needle will be in the targeted fascial plane, a test bolus of normal saline (1-2 mL) will be injected (in real-time) to confirm that the tip was correctly placed, as shown by separation of the fascial layers. After excluding intravascular, the dose of local anaesthetic (0.4 mL/kg 0.25% bupivacaine) will be deposited into the fascial plane visualised in real-time.

PROCEDURE

Intrathecal fentanyl(IT fentanyl)

IT fentanyl group (Group IT; n = 30) will be placed in lateral decubitus position immediately after intubation and catheterisation and receive an IT injection of 2 µg/kg of fentanyl in 0.2 mL/kg of normal saline through a 2-in., 25-gauge Quincke spinal needle inserted at L3-4 or L4-5. The dose of IT fentanyl will be based on a previous study. (15) with this route of fentanyl administration to provide intraoperative analgesia and blunt the stress response in pediatric cardiac anaesthesia. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid, and the injection will be performed with the bevel of the needle oriented in the cephalic direction.

PROCEDURE

IT + PIFB

Patients assigned to the combined IT fentanyl and PIFB (Group IT + PIFB; n = 30) will receive both a PIFB and IT fentanyl, with the use of the methods described for the other two groups.

Trial Locations (2)

21521

Faculty of medicine ,Alexandria university, Alexandria

Faculty of medicine ,Alexandria university, Alexandria

All Listed Sponsors
lead

Alexandria University

OTHER

NCT06882655 - A Combination of Intrathecal Fentanyl and Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery. | Biotech Hunter | Biotech Hunter