Cardiopulmonary Bypass, Corrective Cardiac Surgeries, Median Sternotomy, Pectoral Nerve Block, Pediatric Patients, Transverse Thoracic Plane Block, Ultrasound
Conditions
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.
Interventions
DRUGControl
Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation.
OTHERPectoral 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 .
OTHERTransversus 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 .
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total dose of intraoperative fentanyl | Intraoperatively | The total dose of intraoperative fentanyl will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 12 hours postoperatively | Heart rate (HR) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours |
| Mean arterial pressure | 12 hours postoperatively | Mean arterial pressure (MAP) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours |
| Total consumption of Fentanyl | 12 hours postoperatively | Total consumption of Fentanyl during the 1st 12 hours postoperatively will be recorded |
| Degree of pain | 12 hours postoperatively | Pain will be assessed by the pediatric observational 10-point scale Face, Leg, Activity, Cry, Consolability (FLACC) pain score immediately after admission to intensive care unit (ICU) then at 60 min, 2 hours, 4hours, 8hours and 12 hours postoperatively. If the patient FLACC score equal or more than 4, patient will receive Fentanyl I.V 1 mic /kg . |
| Time of Extubation | 12 hours postoperatively | Time of Extubation will be recorded |
| The incidence of opioid complications | 12 hours postoperatively | The incidence of opioid complications like postoperative nausea and vomiting (PONV), hematoma formation, itching will be recorded |
| The incidence of Local anatectic toxicity | 12 hours postoperatively | The incidence of Local anatectic toxicity like neurologic symptoms (seizures, and ultimately neurologic depression with respiratory arrest, coma, or both) and Cardiovascular symptoms may include an hypertensive , tachycardia, cardiac depression with bradycardia, myocardial depression, conduction block, asystole, and cardiac arrest. |
| Time to 1st rescue analgesia | 12 hours postoperatively | Time to 1st rescue analgesia post operatively which will be defined to be the elapsed time between giving the block and a patient FLACC score equal or more than 4. |
Countries
Egypt
Contacts
Primary ContactMai M Elfiky, Master
Outcome results
None listed