Congenital Heart Disease
Conditions
Brief summary
The serratus anterior plane block (SAPB) is an anterolateral thoracic wall block that was described in 2013 by Blanco et al. who presented it as an alternative to other regional anesthetic techniques. It has been described in adults as an adjunct to general anesthesia or as a primary anesthetic technique for breast surgery, it has not been widely utilized as a primary anesthetic technique in the pediatric population. It was designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax. It provides a viable alternative to paravertebral blockade and central neuraxial block in this patient population The investigators believe that the bilateral two-level injection technique may provide effective analgesia as its efficacy was not properly investigated in corrective heart surgeries with median sternotomy in the pediatric population.
Interventions
PROCEDUREBilateral two level serratus anterior block
bilateral two-level SAPB is performed with the guidance of ultrasound. While the patient is in the supine position with their arms abducted, the US probe is placed in longitudinal plane to visualize and count the ribs down from the clavicle while moving the transducer laterally and distally to identify the muscles overlying the 3rd and 6th ribs at the mid axillary line. Using in- plane approach, a 22-gauge short bevel needle is inserted and advanced to the plane deep to the serratus anterior muscle at the level of 3rd and 6th ribs bilaterally in succession over which a total volume of 1.5ml/kg bupivacaine 0.125% is divided and injected (0.75ml/kg on each side); with total dose not exceeding 2.5 mg/kg.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* Risk Adjustment for Congenital Heart Surgery (RACHS) category 1,2 and 3 Pediatric patients undergoing corrective congenital cardiac surgeries via a median sternotomy
Exclusion criteria
* Refusal of legal guardian. * Patient with congestive heart failure . * Patient undergoing Redo cardiac surgery. * Known allergy to local anesthetics. * Infection at injection site. * Bleeding disorders (drug induced i.e., coumadin; or genetic i.e. hemophilia; or acquired i.e. DIC), coagulopathy: PTT \> 40 seconds, INR \> 1.4, platelet count \< 100x10⁹. * severe renal impairment (estimated Glomerular filtration rate less than 30ml/min/1.73m2) or hepatic insufficiency (Child-Pugh Class B and C). * Neurological disorders because it will be difficult to assess their pain score (e.g. cerebral palsy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative Fentanyl consumption | in the first 24 hours post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative systolic blood pressure | at 1, 2, 4, 8, 12, and 24 hours post-operatively | — |
| Incidence of complications | 24 hours post-operatively | Complications including postoperative vomiting, hematoma formation, ithching, or local anesthetic toxicity |
| Postoperative Face, Leg, Activity, Cry, Consolability "FLACC" pain scale | at 1, 2, 4, 8, 12, and 24 hours post-operatively | Postoperative pain intensity measured by FLACC scale in children. The score ranges from 0 to 10, where 0 indicates no pain, 1-3 mild discomfort, 4-6 moderate pain, and 7-10 severe pain/discomfort. |
| Time to first rescue analgesia | recorded during the first 24 hours after surgery (in hours unit) | first incidence of fentanyl bolus in the postoperative phase if FLACC score is 4 or more, targeting FLACC score of 3 or less |
| intraoperative heart rate | Intraoperative period | After induction of anesthesia (baseline), after skin incision, after sternotomy, during aortic cannulation, and 15 minutes after weaning from cardiopulmonary bypass |
| Intraoperative systolic blood pressure | Intraoperative period | After induction of anesthesia (baseline), after skin incision, after sternotomy, during aortic cannulation, and 15 minutes after weaning from cardiopulmonary bypass |
| Intraoperative additional boluses of fentanyl | Intraoperative period | additional boluses of fentanyl at a dose of 0.5 µg/kg whenever HR or SBP increased more than 20% of baseline |
| Time to extubation | 24 hours post-operatively | Either within 2, 6, 12, or 24 hours after surgery |
| Postoperative heart rate | at 1, 2, 4, 8, 12, and 24 hours post-operatively | — |
Countries
Egypt
Outcome results
None listed