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

Pediatric Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05536063
• Other study ID #: ESPB in ped. cardiac surgeries
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: May 2025

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: Amonios khalil, assistan lecturer
• Phone: 01023466456
• Email: amonios_khalil[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Pediatric Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Aprà 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. — View Citation

Karacaer F, Biricik E, Ilginel M, Tunay D, Topçuoglu S, Ünlügenç 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	total analgesic consumption postoperative	total amount of postoperative analgesic consumption	for 48 hours postextubation