An interventional study of Bilateral two level serratus anterior block in Congenital Heart Disease, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
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.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Bilateral two level serratus anterior block
Intraoperative fentanyl without nerve 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.
Also known as: Bilateral SAPB
Postoperative Fentanyl consumption
Time frame: in the first 24 hours post-operatively
intraoperative heart rate
After induction of anesthesia (baseline), after skin incision, after sternotomy, during aortic cannulation, and 15 minutes after weaning from cardiopulmonary bypass
Time frame: Intraoperative period
Intraoperative systolic blood pressure
After induction of anesthesia (baseline), after skin incision, after sternotomy, during aortic cannulation, and 15 minutes after weaning from cardiopulmonary bypass
Time frame: Intraoperative period
Intraoperative additional boluses of fentanyl
additional boluses of fentanyl at a dose of 0.5 µg/kg whenever HR or SBP increased more than 20% of baseline
Time frame: Intraoperative period
Postoperative heart rate
Time frame: at 1, 2, 4, 8, 12, and 24 hours post-operatively
Postoperative systolic blood pressure
Time frame: at 1, 2, 4, 8, 12, and 24 hours post-operatively
Postoperative Face, Leg, Activity, Cry, Consolability "FLACC" pain scale
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 frame: at 1, 2, 4, 8, 12, and 24 hours post-operatively
Time to first rescue analgesia
first incidence of fentanyl bolus in the postoperative phase if FLACC score is 4 or more, targeting FLACC score of 3 or less
Time frame: recorded during the first 24 hours after surgery (in hours unit)
Time to extubation
Either within 2, 6, 12, or 24 hours after surgery
Time frame: 24 hours post-operatively
Incidence of complications
Complications including postoperative vomiting, hematoma formation, ithching, or local anesthetic toxicity
Time frame: 24 hours post-operatively
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Cairo University