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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings