Trials / Not Yet Recruiting

Not Yet RecruitingNCT06882655

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

A Combination of Intrathecal Fentanyl and Ultrasound-Guided Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery: A Randomized Controlled Trial

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 90 (estimated)

Sponsor: Alexandria University · Academic / Other
Sex: All
Age: 6 Months – 6 Years
Healthy volunteers: Not accepted

Summary

Detailed description

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. Sternal wound pain has been linked to diminished patient satisfaction, delirium, and a spectrum of cardiovascular complications, including hypotension, tachycardia, arrhythmias, and respiratory issues such as stasis of bronchial secretions, atelectasis, and pneumonia. Pain management after cardiac surgery is critical to enhancing recovery. Various modalities are available for managing postoperative pain in cardiac surgery. These modalities include opioids, local anaesthetic techniques such as local anaesthetic infiltration, and neuraxial blocks (epidural and paravertebral). Additionally, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are feasible options for pain control. Furthermore, adjunct analgesics such as steroids, ketamine, α2 agonists, and anticonvulsants are also employed for effective pain management.Opioids can elicit various adverse effects, such as delayed tracheal extubation, respiratory depression, sedation, ileus, nausea, vomiting, immunosuppression, cough suppression, drowsiness, and an increased risk of chronic pain. 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. PIFPB has been an effective technique for pain control after sternotomy . However, a high incidence of non-sternal wound pain was observed with this technique of fascial plain block both in adults and paediatrics after cardiac surgery . 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

Interventions

Type	Name	Description
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.

Timeline

Start date: 2025-04-20
Primary completion: 2025-10-10
Completion: 2025-10-10
First posted: 2025-03-18
Last updated: 2025-04-15

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06882655. Inclusion in this directory is not an endorsement.