Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial

The aim of this study is to figure out the efficacy of dexamethasone addition to bupivacaine versus bupivacaine alone in bilateral erector spinae plane block on postoperative analgesia after pediatric cardiac surgeries

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cardiac Surgery
• Intervention / Treatment: Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries

Detailed Description

The recently introduced ultrasound-guided interfascial plane block, bilateral erector spinae plane block (ESPB) is a viable option for management of postoperative pain after midline sternotomy. It is expected to provide an analgesic cover spanning the entire thorax at the desired dermatomes including the midline, which could prove beneficial for cardiac surgery through midline sternotomy.

Indications for ESPB for postoperative analgesia in pediatric surgeries to date include thoracotomy, video-assisted thoracoscopic surgery, vascular ring repair and sternotomy.

Dexamethasone is a synthetic glucocorticoid acting as an anti- inflammatory. It inhibits the release of inflammatory mediators such as interleukins and cytokines. Several studies have shown that a preoperative dose of dexamethasone added to local anesthetic agents has promising results in reducing postoperative pain and improving the quality of analgesia

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amonios khalil, assistan lecturer; Phone Number: 01023466456; Email: amonios_khalil@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I and II
• Undergoing cardiac surgical procedures through a midline sternotomyPreoperative ejection fraction <35%

Exclusion Criteria:

• Low-cardiac-output syndrome
• Ventricular arrhythmia
• Preoperative inotropic support
• Known allergies to any of the study drugs
• Intubation for more than 3 hours or re-exploration
• A redo or emergency surgery
• Contraindications to regional anesthesia as coagulopathy and infection in site of block.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side	Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries; The ESPB will be performed after induction of anesthesia, endotracheal tube insertion and before the start of operation, with the child in a right lateral decubitus position under aseptic precautions. A high frequency linear ultrasound transducer will be placed over the T4 transverse process lateral to the spinous process. After identifying the muscles above the hyperechoic transverse process image, a 5-cm 22 gauge needle will be inserted in-plane in a cephalo-caudad direction. The endpoint is defined as the needle pointing to the tip of transverse process piercing the erector spinae muscle. The local anesthetic will be deposited at this position, After careful negative aspiration, local anesthetic, according to study groups , The process will be repeated on thecontralateral side
Experimental: Group B; bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) + dexamethasone 0.1 mg/kg for each side	Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries; The ESPB will be performed after induction of anesthesia, endotracheal tube insertion and before the start of operation, with the child in a right lateral decubitus position under aseptic precautions. A high frequency linear ultrasound transducer will be placed over the T4 transverse process lateral to the spinous process. After identifying the muscles above the hyperechoic transverse process image, a 5-cm 22 gauge needle will be inserted in-plane in a cephalo-caudad direction. The endpoint is defined as the needle pointing to the tip of transverse process piercing the erector spinae muscle. The local anesthetic will be deposited at this position, After careful negative aspiration, local anesthetic, according to study groups , The process will be repeated on thecontralateral side
No Intervention: Group C; control group will receive the standard analgesic regimen only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale	The primary outcome of this study is the intensity of postoperative pain that will be assessed using Face, Legs, Activity, Cry and Consolability, minimum value 0 and maximum value 10, high scores means worse outcome (FLACC) pain scale	Postoperative pain assessment is performed using FLACC pain scale at fixed time intervasl for 48 hours post extubation,

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total analgesic consumption postoperative	total amount of postoperative analgesic consumption	for 48 hours postextubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta endorphins levels	comparison between preoperative and postoperative levels of B-endorphins	Blood samples for postoperative beta-endorphins at 2, 24, and 48 hours post-extubation

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
• Karacaer F, Biricik E, Ilginel M, Tunay D, Topcuoglu S, Unlugenc H. Bilateral erector spinae plane blocks in children undergoing cardiac surgery: A randomized, controlled study. J Clin Anesth. 2022 Sep;80:110797. doi: 10.1016/j.jclinane.2022.110797. Epub 2022 Apr 28.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ESPB in ped. cardiac surgeries

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No