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
Launched by CAIRO UNIVERSITY · May 20, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating two different methods of pain control for young children undergoing heart surgery. Specifically, it compares the effectiveness of a technique called the pectoral nerve block (PECS) and another technique called the transverse thoracic plane block (TTPB). Both methods aim to help manage pain during and after surgery, which is important for the child's recovery.
To be eligible for the trial, children between the ages of 6 months and 7 years who are scheduled for certain types of heart surgeries that require a specific surgical incision are invited to participate. Parents or guardians will be informed about the study and will need to give their consent for their child to take part. If a child joins the trial, they can expect to receive one of the two pain management techniques during their surgery, and researchers will monitor their pain levels and recovery to see which method works better. It’s a great opportunity to help improve pain management for kids in the future while also ensuring that safety and well-being are prioritized throughout the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, , Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported