A Combination of Intrathecal Fentanyl and Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery.
Launched by ALEXANDRIA UNIVERSITY · Mar 17, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new way to manage pain after pediatric heart surgery. Specifically, it will look at using a combination of two pain relief techniques: a method called intrathecal fentanyl, which involves delivering pain medication directly into the spinal fluid, and a pecto-intercostal fascial block, which is a type of local anesthesia that numbs the area around the chest. The goal is to help children recover more comfortably and quickly after surgery, as many experience severe pain that can last long after the operation.
The trial is open to children aged 6 months to 6 years who are scheduled for surgery to fix congenital heart defects. However, some children may not be eligible if they have had previous heart surgeries, need certain medications, or have other health issues that could complicate their recovery. If a child participates, they can expect to receive these pain management techniques during their surgery and be closely monitored afterward to see how well they work. This study aims to improve pain relief methods and support better healing for young patients undergoing heart surgery.
Gender
ALL
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.
About Alexandria University
Alexandria University, a leading academic institution in Egypt, is dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. With a strong emphasis on collaboration and interdisciplinary approaches, the university leverages its extensive resources and expertise to conduct rigorous studies that address pressing health challenges. By fostering partnerships with healthcare professionals, industry leaders, and regulatory bodies, Alexandria University aims to contribute to the global body of medical knowledge and enhance the quality of patient care through evidence-based findings.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Alexandria, , Egypt
Patients applied
Trial Officials
Islam Elbardan, Dr
Principal Investigator
University of Alexandria
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported