Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT06221150
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
6 Years
Study:
NCT06221150
Study Brief:
Protocol Section:
NCT06221150