Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy

February 11, 2026 updated by: Mai Madkour, Cairo University

Ultrasound-guided Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy : A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Abu El Reesh pediatric university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAPB group
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
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.
Other Names:
  • Bilateral SAPB
No Intervention: control group
Intraoperative fentanyl without nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative Fentanyl consumption
Time Frame: in the first 24 hours post-operatively
in the first 24 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative heart rate
Time Frame: Intraoperative period
After induction of anesthesia (baseline), after skin incision, after sternotomy, during aortic cannulation, and 15 minutes after weaning from cardiopulmonary bypass
Intraoperative period
Intraoperative systolic blood pressure
Time Frame: Intraoperative period
After induction of anesthesia (baseline), after skin incision, after sternotomy, during aortic cannulation, and 15 minutes after weaning from cardiopulmonary bypass
Intraoperative period
Intraoperative additional boluses of fentanyl
Time Frame: Intraoperative period
additional boluses of fentanyl at a dose of 0.5 µg/kg whenever HR or SBP increased more than 20% of baseline
Intraoperative period
Postoperative heart rate
Time Frame: at 1, 2, 4, 8, 12, and 24 hours post-operatively
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
at 1, 2, 4, 8, 12, and 24 hours post-operatively
Time to first rescue analgesia
Time Frame: 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
recorded during the first 24 hours after surgery (in hours unit)
Time to extubation
Time Frame: 24 hours post-operatively
Either within 2, 6, 12, or 24 hours after surgery
24 hours post-operatively
Incidence of complications
Time Frame: 24 hours post-operatively
Complications including postoperative vomiting, hematoma formation, ithching, or local anesthetic toxicity
24 hours post-operatively
Postoperative Face, Leg, Activity, Cry, Consolability "FLACC" pain scale
Time Frame: 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.
at 1, 2, 4, 8, 12, and 24 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-341-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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