Pain management technique for children undergoing heart surgery
Ultrasound-guided Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy : A Randomized Controlled Trial
This study is testing a new pain management technique for children having heart surgery to see if it works better than standard methods.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 6 Months to 6 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06221150 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a bilateral two-level serratus anterior plane block (SAPB) as a pain management technique in pediatric patients undergoing corrective congenital cardiac surgeries via median sternotomy. The SAPB aims to provide complete analgesia of the thoracic region by blocking intercostal nerves, potentially serving as a safer alternative to traditional anesthetic methods. The study will compare outcomes between patients receiving the SAPB and those in a control group to assess its efficacy in this specific surgical context.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients classified under RACHS categories 1, 2, and 3 who are scheduled for corrective congenital cardiac surgeries.
Not a fit: Patients with severe comorbidities, such as congestive heart failure or significant bleeding disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly improve pain management and recovery for pediatric patients undergoing heart surgery.
How similar studies have performed: While the SAPB has been utilized in adults, its application in pediatric cardiac surgery is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Risk Adjustment for Congenital Heart Surgery (RACHS) category 1,2 and 3 Pediatric patients undergoing corrective congenital cardiac surgeries via a median sternotomy Exclusion Criteria: * • Refusal of legal guardian. * Patient with congestive heart failure . * Patient weaned from cardiopulmonary bypass on high doses of inotropic support (Adrenaline or noradrenaline more than 200ng/kg/min). * Patient undergoing Redo cardiac surgery. * Known allergy to local anesthetics. * Infection at injection site. * Bleeding disorders (drug induced i.e., coumadin; or genetic i.e. hemophilia; or acquired i.e. DIC), coagulopathy: PTT \> 40 seconds, INR \> 1.4, platelet count \< 100x10⁹. * severe renal or hepatic insufficiency. * Neurological disorders because it will be difficult to assess their pain score (e.g. cerebral palsy).
Where this trial is running
Cairo
- Pediatric University Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mai A Madkour, MD
- Email: maimadkour@kasralainy.edu.eg
- Phone: 01223657694
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.