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Congenital Heart DiseaseNCT06221150

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

A study testing Bilateral two level serratus anterior block in people with Congenital Heart Disease, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 6 years
Conditions the study is for
Congenital Heart Disease
What is being tested?
Bilateral two level serratus anterior block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
20 Jan 2025to 30 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Risk Adjustment for Congenital Heart Surgery (RACHS) category 1,2 and 3 Pediatric patients undergoing corrective congenital cardiac surgeries via a median sternotomy

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Abu El Reesh pediatric university hospital

    Cairo

Other trials in Egypt

About this study

Official title: 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.

Being tested
Bilateral two level serratus anterior block
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral two level serratus anterior blockProcedure or surgery

    Also called Bilateral SAPB

    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.

Study groups in NCT06221150
Study groupRoleWhat they receive
SAPB groupExperimentalbilateral 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.
Receives: Procedure: Bilateral two level serratus anterior block
control groupNo interventionIntraoperative fentanyl without nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Fentanyl consumption

    Measured: in the first 24 hours post-operatively

Secondary outcomes (9)

  1. intraoperative heart rate

    After induction of anesthesia (baseline), after skin incision, after sternotomy, during aortic cannulation, and 15 minutes after weaning from cardiopulmonary bypass

    Measured: Intraoperative period

  2. 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

    Measured: Intraoperative period

  3. 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

    Measured: Intraoperative period

  4. Postoperative heart rate

    Measured: at 1, 2, 4, 8, 12, and 24 hours post-operatively

  5. Postoperative systolic blood pressure

    Measured: at 1, 2, 4, 8, 12, and 24 hours post-operatively

  6. 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.

    Measured: at 1, 2, 4, 8, 12, and 24 hours post-operatively

  7. 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

    Measured: recorded during the first 24 hours after surgery (in hours unit)

  8. Time to extubation

    Either within 2, 6, 12, or 24 hours after surgery

    Measured: 24 hours post-operatively

  9. Incidence of complications

    Complications including postoperative vomiting, hematoma formation, ithching, or local anesthetic toxicity

    Measured: 24 hours post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start20 Jan 2025
  3. Primary completion30 Jan 2026
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06221150
Sponsor's protocol ID
MD-341-2023
Status last verified
Jan 2025
First submitted
5 Jan 2024
Last updated
13 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mayes J, Davison E, Panahi P, Patten D, Eljelani F, Womack J, Varma M. An anatomical evaluation of the serratus anterior plane block. Anaesthesia. 2016 Sep;71(9):1064-9. doi: 10.1111/anae.13549. Epub 2016 Jul 20.

    PubMed 27440171

  • Ren Y, Li L, Gao J, Hua L, Zheng T, Wang F, Zhang J. Regional Analgesia in Pediatric Cardiothoracic Surgery: A Bayesian Network Meta-Analysis. J Cardiothorac Vasc Anesth. 2025 Apr;39(4):1037-1048. doi: 10.1053/j.jvca.2024.12.043. Epub 2025 Jan 9.

    PubMed 39880711

  • Egbuta C, Mason KP. Current State of Analgesia and Sedation in the Pediatric Intensive Care Unit. J Clin Med. 2021 Apr 23;10(9):1847. doi: 10.3390/jcm10091847.

    PubMed 33922824

  • Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.

    PubMed 21955825

  • Shenkman Z, Shir Y, Weiss YG, Bleiberg B, Gross D. The effects of cardiac surgery on early and late pulmonary functions. Acta Anaesthesiol Scand. 1997 Oct;41(9):1193-9. doi: 10.1111/j.1399-6576.1997.tb04865.x.

    PubMed 9366943

  • Sasseron AB, Figueiredo LC, Trova K, Cardoso AL, Lima NM, Olmos SC, Petrucci O. Does the pain disturb the respiratory function after open heart surgery? Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):490-6. doi: 10.1590/s0102-76382009000500010. English, Portuguese.

    PubMed 20305922

  • Ergun A, Sirlak M. [Pulmonary function test before and after operation of coronary artery by-pass surgery]. Tuberk Toraks. 2003;51(1):17-22. Turkish.

    PubMed 15100899

  • Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.

    PubMed 30197534

  • Guimaraes-Pereira L, Reis P, Abelha F, Azevedo LF, Castro-Lopes JM. Persistent postoperative pain after cardiac surgery: a systematic review with meta-analysis regarding incidence and pain intensity. Pain. 2017 Oct;158(10):1869-1885. doi: 10.1097/j.pain.0000000000000997.

    PubMed 28767509

  • He Y, Xu M, Li Z, Deng L, Kang Y, Zuo Y. Safety and feasibility of ultrasound-guided serratus anterior plane block and intercostal nerve block for management of post-sternotomy pain in pediatric cardiac patients: A prospective, randomized trial. Anaesth Crit Care Pain Med. 2023 Dec;42(6):101268. doi: 10.1016/j.accpm.2023.101268. Epub 2023 Jun 24.

    PubMed 37364851

  • Kupeli I, Adilovic AS. The "Feasibility" And "Safety" Of Ultrasound Guided Bilateral Two Level Serratus Anterior Plane Block in Children With Median Sternotomy Pain: A Case Series. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):270-273. doi: 10.1053/j.jvca.2020.03.020. Epub 2020 Mar 19. No abstract available.

    PubMed 32360008

  • Abdelbaser II, Mageed NA. Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study. J Clin Anesth. 2020 Dec;67:110002. doi: 10.1016/j.jclinane.2020.110002. Epub 2020 Jul 24.

    PubMed 32717448

  • Malviya S, Voepel-Lewis T, Burke C, Merkel S, Tait AR. The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatr Anaesth. 2006 Mar;16(3):258-65. doi: 10.1111/j.1460-9592.2005.01773.x.

    PubMed 16490089

  • Voepel-Lewis T, Zanotti J, Dammeyer JA, Merkel S. Reliability and validity of the face, legs, activity, cry, consolability behavioral tool in assessing acute pain in critically ill patients. Am J Crit Care. 2010 Jan;19(1):55-61; quiz 62. doi: 10.4037/ajcc2010624.

    PubMed 20045849

  • Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

    PubMed 9220806

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral two level serratus anterior block in people with Congenital Heart Disease, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Fentanyl consumption (time frame: in the first 24 hours post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06221150, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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