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Compares treatment options for Ultrasound
Official title 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
ClinicalTrials.gov ID: NCT06984276
What this study is testing
What is Control?
Control is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ultrasound.
Also referred to as Fentanyl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 7
You may be able to join if
- 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.
You likely can't join if
- 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])...
- Known or suspected allergy to any of the studied drugs.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.