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

NCT06882655 | Not Yet Recruiting

• 1 other identifier: IRB NO : 00012098
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Cardiac surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent chronic pain in approximately 35% of cases after one year. Recently, thoracic myofascial plane blocks with ultrasound guidance as part of multimodal analgesia have contributed to a faster recovery after surgery. De la Torre et al. first described pectointercostal fascial plane block (PIFPB) for breast surgery. Local anaesthetics are injected between the pectoralis major and internal intercostal muscles close to the sternum to block the anterior cutaneous branch of the second-to-sixth thoracic intercostal nerves.The use of intrathecal (IT) opioids with or without local anaesthetics (LA) is a popular analgesic technique around the world for the management of postoperative pain. Unlike IT administration of LA, IT opioids produce 'segmental' analgesia and are not associated with muscle weakness, loss of proprioception or sympathetic block. IT opioids can be administered as an adjunct to general anaesthesia or combined with LA and administered during spinal anaesthesia for surgery. It is one of the easiest, most reliable and cost-effective methods for pain relief. Intrathecal opioid administration can provide more intense analgesia than the IV route and has the advantages of simplicity and reliability

Conditions

Postoperative Pain; Pediatric Open Heart Surgery

Keywords

Intercostal Fascial Block; intrathecal fentanyl; Paediatric Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• To investigate how effectively three distinct pain management techniques can reduce the stress response that patients experience after undergoing cardiac surgery.

  Serum cortisol and plasma epinephrine and norepinephrine will be measured.

  after the procedure24 hour

Secondary Outcomes (5)

• To conduct a comparative analysis of the analgesic efficacy of each pain management method.

  every 30 minutes for the first six postoperative hours and every 6 hours during the first, second, and third postoperative days.

• To meticulously document and evaluate any potential adverse effects associated with these pain management strategies, ensuring patient safety.

  first 30 min after block administration and 24 hour postoperatively

• to determine which technique offers the most effective in early extubation

  in first 24 hour postoperatively

• to determine the duration of analgesic effect of technique post operative

  in first 24 hour postoperatively

• to determine which technique offers lesser consumption of fentanyl

  intraoperative during the procedure and first 3 days post operative

Study Arms (3)

Pecto-Intercostal Fascial Block group

EXPERIMENTAL

The PIFB group (Group PIFB; n = 30) will receive a pecto-intercostal-fascial plane block (PIFB). The blocks 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: PIFB group

Intrathecal fentanyl group

ACTIVE COMPARATOR

The children in the 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: Intrathecal fentanyl(IT fentanyl)

intrathecal fentanyl and pectointercostal fascial block

ACTIVE COMPARATOR

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.

Procedure: IT + PIFB

Interventions

PIFB group PROCEDURE

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.

Pecto-Intercostal Fascial Block group

Intrathecal fentanyl(IT fentanyl) PROCEDURE

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.

Intrathecal fentanyl group

IT + PIFB PROCEDURE

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.

intrathecal fentanyl and pectointercostal fascial block

Eligibility Criteria

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

You may qualify if:

• The enrolled patients ranged in age from 6 months to 6 years,
• patients scheduled for surgical repair of congenital heart defects.

You may not qualify if:

• The preoperative criteria include a history of previous cardiac surgery, hemodynamic instability, the need for mechanical ventilation, and the requirement for vasoactive drugs, opioids, or corticosteroids.
• During the intraoperative phase, who use of deep hypothermic circulatory arrest and the necessity for vasoactive drugs, excluding the temporary use of dopamine and dobutamine at a maximum dose of 10 µg/kg/min.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, 21521, Egypt

Location

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, 21521, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Islam Elbardan, Dr

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham ELgoweini, Prof.Dr

CONTACT

00201287740750; ethics.comm@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: April 20, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)