Comparing two pain management techniques for children undergoing heart surgery
Official title: Efficacy Of 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: A Randomized Controlled Trial.
Run by Cairo University · NCT06984276 · Data updated 2026-11-12
This study is testing which of two pain management techniques works better for children having heart surgery to help them recover faster and feel less pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 7 Years |
| Sex | All |
| Enrollment | 81 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | September 30, 2024 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | May 30, 2025 |
| Trial ID | NCT06984276 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients aged 6 months to 7 years undergoing cardiac surgeries that require cardiopulmonary bypass via a median sternotomy.
✕Probably not a fit
Patients with severe pulmonary hypertension, bleeding disorders, or those requiring preoperative mechanical ventilation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blinded study aims to evaluate the effectiveness of bilateral ultrasound-guided pectoral nerve blocks versus bilateral transverse thoracic plane blocks for pain control in pediatric patients undergoing corrective cardiac surgeries. The study focuses on improving perioperative analgesia to facilitate early recovery and discharge from the Intensive Care Unit. By comparing these two regional anesthesia techniques, the research seeks to determine which method provides better pain relief and minimizes the use of traditional pain medications, which can have adverse effects.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for pediatric cardiac surgery patients, enhancing recovery times and overall outcomes.
How similar studies have gone: While the pectoral nerve block has been established for adult breast surgery, its application in pediatric cardiac surgeries is relatively novel, indicating that this study explores an untested approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Cairo University
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Mai M Elfiky, Master
- Email: maielfiky45@gmail.com
- Phone: 00201110404608
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.