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

NCT05536063 | Unknown

• 1 other identifier: ESPB in ped. cardiac surgeries
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pediatric Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• total analgesic consumption postoperative

  for 48 hours postextubation

Other Outcomes (1)

• Beta endorphins levels

  Blood samples for postoperative beta-endorphins at 2, 24, and 48 hours post-extubation

Study Arms (3)

group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Group C

NO INTERVENTION

control group will receive the standard analgesic regimen only

Interventions

bilateral erector spinae plane block in pediatric cardiac surgeries PROCEDURE

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

Group B; group A

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 35489304 BACKGROUND

• 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.

  PMID: 24949192 BACKGROUND

Central Study Contacts

Amonios khalil, assistan lecturer

CONTACT

01023466456; amonios_khalil@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at anaesthesia and ICU department

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 10, 2022
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: September 10, 2022

Record last verified: 2022-09