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Search / Trial NCT06221150

Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy

Launched by CAIRO UNIVERSITY · Jan 22, 2024

Trial Information

Current as of July 05, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage pain for children undergoing heart surgery, specifically those with congenital heart disease. The researchers are testing a technique called the bilateral two-level serratus anterior plane block (SAPB), which is designed to provide effective pain relief during and after surgery. This method has been used in adults but is being explored for its effectiveness in pediatric patients who need corrective heart surgery through a method called median sternotomy (which involves making an incision down the middle of the chest).

To participate in this trial, children aged 6 months to 18 years who are undergoing certain types of heart surgeries may be eligible, especially those classified as low to moderate risk. However, some children may not qualify, such as those with certain heart conditions, allergies to anesthesia, or other significant medical issues. If they join the trial, participants will receive the SAPB along with their usual care, and the team will closely monitor their pain levels and overall recovery. This trial aims to find a safer and more effective way to manage pain in young patients after heart surgery.

Gender

ALL

Eligibility 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).

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Cairo, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported