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

NCT06221150 | Completed

• 1 other identifier: MD-341-2023
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Postoperative Fentanyl consumption

  in the first 24 hours post-operatively

Secondary Outcomes (9)

• intraoperative heart rate

  Intraoperative period

• Intraoperative systolic blood pressure

  Intraoperative period

• Intraoperative additional boluses of fentanyl

  Intraoperative period

• Postoperative heart rate

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

• Postoperative systolic blood pressure

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

Study Arms (2)

SAPB group

EXPERIMENTAL

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

control group

NO INTERVENTION

Intraoperative fentanyl without nerve block

Interventions

Bilateral two level serratus anterior block PROCEDURE

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

SAPB group

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abu El Reesh pediatric university hospital

Cairo, Egypt

Location

Related Publications (19)

• 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.

  PMID: 27440171 BACKGROUND

• 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.

  PMID: 39880711 BACKGROUND

• 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.

  PMID: 33922824 BACKGROUND

• 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.

  PMID: 21955825 BACKGROUND

• 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.

  PMID: 9366943 BACKGROUND

• 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.

  PMID: 20305922 BACKGROUND

• 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.

  PMID: 15100899 BACKGROUND

• 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.

  PMID: 30197534 BACKGROUND

• 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.

  PMID: 28767509 BACKGROUND

• 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.

  PMID: 37364851 BACKGROUND

• 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.

  PMID: 32360008 BACKGROUND

• 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.

  PMID: 32717448 BACKGROUND

• 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.

  PMID: 16490089 BACKGROUND

• 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.

  PMID: 20045849 BACKGROUND

• 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.

  PMID: 9220806 BACKGROUND

• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

  PMID: 23923989 BACKGROUND

• Tewari P, Hajela K, Ahmad SS. Bilateral superficial serratus anterior plane block in a pediatric patient for post-operative analgesia undergoing asd repair via median sternotomy- A case report. Ann Card Anaesth. 2022 Jan-Mar;25(1):116-118. doi: 10.4103/aca.aca_113_21.

  PMID: 35075035 BACKGROUND

• Devarajan J, Balasubramanian S, Shariat AN, Bhatt HV. Regional Analgesia for Cardiac Surgery. Part 2: Peripheral Regional Analgesia for Cardiac Surgery. Semin Cardiothorac Vasc Anesth. 2021 Dec;25(4):265-279. doi: 10.1177/10892532211002382. Epub 2021 Apr 8.

  PMID: 33827348 BACKGROUND

• Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.

  PMID: 32062870 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 24, 2024
• Study Start: January 20, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)