Status:
RECRUITING
Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy
Lead Sponsor:
Cairo University
Conditions:
Ultrasound
Pectoral Nerve Block
Eligibility:
All Genders
6-7 years
Phase:
NA
Brief Summary
This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transvers...
Detailed Description
Good perioperative analgesia in cardiac surgical patients helps early recovery, ambulation, and early discharge from the Intensive Care Unit (ICU). Traditional use of nonsteroidal anti-inflammatory dr...
Eligibility Criteria
Inclusion
- Age: 6 months - 7 years.
- Gender: both sexs .
- Risk Adjustment for Congenital Heart Surgery (RACHS) II and III.
- Patients undergoing cardiac surgeries requiring cardiopulmonary bypass with midline sternotomy incision.
Exclusion
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Patients in coma, mental retardation, neurological disease, or on drugs affecting the behaviour.
- Preoperative inotropic drug infusion.
- (Bleeding disorders (drug induced i.e., coumadin; or genetic e.g. hemophilia; or acquired e.g. disseminated intravascular coagulation \[DIC\]), coagulopathy: Partial Thromboplastin Time (PTT) \> 40 seconds, International Normalized Ratio (INR) \> 1.4, platelet count \< 100x10⁹.
- Known or suspected allergy to any of the studied drugs.
- Severe pulmonary hypertension (mean resting blood pressure in pulmonary arteries is above 70mmHg).
- Cardiopulmonary bypass time more than 90 minutes.
- local infection.
- Significant Renal impairment (creatinine more than 1.2mg/dl)
- Aortic cross-clamp time more than 45 minutes.
- Total time from induction till intensive Care Unit (ICU) transfer more than 4 hours and 30 mins.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06984276
Start Date
September 30 2024
End Date
December 30 2025
Last Update
May 30 2025
Active Locations (1)
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1
Cairo University
Cairo, Egypt, 12613