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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control, Pectoral nerves (PECS), Transversus thoracic muscle plane block (TTPB).
- Who it may be relevant to
- Registry conditions: Ultrasound, Pectoral Nerve Block, Transverse Thoracic Plane Block, Pediatric Patients. Basic parameters: 6 months — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Drug Control
Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation. - Other Pectoral nerves (PECS)
This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus ultrasound guided bilateral pectoral nerves (PECS) Block which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side . - Other Transversus thoracic muscle plane block (TTPB)
This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus Ultrasound guided bilateral transversus thoracic muscle plane block (TTPB) which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
Primary outcome measures
- The total dose of intraoperative fentanyl [Time frame: Intraoperatively]
Secondary outcome measures (8)
- Degree of pain [Time frame: 12 hours postoperatively]
- Heart rate [Time frame: 12 hours postoperatively]
- Mean arterial pressure [Time frame: 12 hours postoperatively]
- Total consumption of Fentanyl [Time frame: 12 hours postoperatively]
- Time to 1st rescue analgesia [Time frame: 12 hours postoperatively]
- Time of Extubation [Time frame: 12 hours postoperatively]
- The incidence of opioid complications [Time frame: 12 hours postoperatively]
- The incidence of Local anatectic toxicity [Time frame: 12 hours postoperatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06984276 · MD-263-2024