Clinical trial NCT06882655: A Combination of Intrathecal Fentanyl and Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery.
Official title: A Combination of Intrathecal Fentanyl and Ultrasound-Guided Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Pediatric Open Heart Surgery
Keywords: Intercostal Fascial Block
intrathecal fentanyl
Paediatric Cardiac Surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.
* Postoperative exclusion conditions will include prolonged mechanical ventilation lasting more than 24 hours, hemodynamic instability, and the need for high doses of opioids or sedatives.

Primary outcomes:
measure: To investigate how effectively three distinct pain management techniques can reduce the stress response that patients experience after undergoing cardiac surgery.
timeFrame: after the procedure24 hour
Secondary outcomes:
measure: To conduct a comparative analysis of the analgesic efficacy of each pain management method.
timeFrame: every 30 minutes for the first six postoperative hours and every 6 hours during the first, second, and third postoperative days.
measure: To meticulously document and evaluate any potential adverse effects associated with these pain management strategies, ensuring patient safety.
timeFrame: first 30 min after block administration and 24 hour postoperatively
measure: to determine which technique offers the most effective in early extubation
timeFrame: in first 24 hour postoperatively
measure: to determine the duration of analgesic effect of technique post operative
timeFrame: in first 24 hour postoperatively
measure: to determine which technique offers lesser consumption of fentanyl
timeFrame: intraoperative during the procedure and first 3 days post operative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of medicine ,Alexandria university
city: Alexandria
country: Egypt
facility: Faculty of medicine ,Alexandria university
Study officials:
affiliation: University of Alexandria
name: Islam Elbardan, Dr
role: PRINCIPAL_INVESTIGATOR
References: