Clinical trial NCT06984276: 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
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound
Pectoral Nerve Block
Transverse Thoracic Plane Block
Pediatric Patients
Corrective Cardiac Surgeries
Cardiopulmonary Bypass
Median Sternotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 81
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries.

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 drugs (NSAIDs) and opioids associated with adverse effect commonly used for pain control postoperative.

The transversus thoracic muscle plane block (TTPB) is a recently advised regional anesthesia method that provides analgesia to the anterior chest wall and was initially introduced by Ueshima et al. in 2015 .

The pectoral nerves (PECS) block has evolved to be two different types: PECS I and PECS II. In PECS I block, anesthetic is injected in the interfacial plane between the pectoralis major and minor muscles at the 3rd rib, blocking the lateral and medial pectoral nerves. The PECS II block, which was also developed by Blanco in 2012.

The PECS block has been well established for its use in breast surgery for the adult population. , However, there has been a recent push in the last couple of years to find more about other uses for these types of blocks, especially in cardiac surgeries.

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.

Primary outcomes:
measure: The total dose of intraoperative fentanyl
timeFrame: Intraoperatively
Secondary outcomes:
measure: Degree of pain
timeFrame: 12 hours postoperatively
measure: Heart rate
timeFrame: 12 hours postoperatively
measure: Mean arterial pressure
timeFrame: 12 hours postoperatively
measure: Total consumption of Fentanyl
timeFrame: 12 hours postoperatively
measure: Time to 1st rescue analgesia
timeFrame: 12 hours postoperatively
measure: Time of Extubation
timeFrame: 12 hours postoperatively
measure: The incidence of opioid complications
timeFrame: 12 hours postoperatively
measure: The incidence of Local anatectic toxicity
timeFrame: 12 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: