Clinical Trial

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

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Record status
This record was last updated April 15, 2025 (before its estimated October 10, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-17; most recent amendment 2025-04-12.
Trial Details
NCT Number NCT06882655
Lead Sponsor Alexandria University
Conditions Postoperative Pain, Pediatric Open Heart Surgery
Enrollment 90 participants
Start Date 2025-04-20
Primary Completion 2025-10-10 (estimated)
Study Completion 2025-10-10 (estimated)
Updated on ClinicalTrials.gov 2025-04-15