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

Not Applicable

Not yet recruiting

• Conditions: Pediatric Cardiac Surgery
• Interventions: Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries

• Registration Number: NCT05536063
• Lead Sponsor: Assiut University

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

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 Timeline

• Study First Submitted: 2022-08-23
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10
• Study Start: 2023-05
• Primary Completion: 2024-12
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	bilateral erector spinae plane block in pediatric cardiac surgeries	bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side
Group B	bilateral erector spinae plane block in pediatric cardiac surgeries	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

Primary Outcome Measures

Name	Time	Method
postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale	Postoperative pain assessment is performed using FLACC pain scale at fixed time intervasl for 48 hours post extubation,	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

Secondary Outcome Measures

Name	Time	Method
total analgesic consumption postoperative	for 48 hours postextubation	total amount of postoperative analgesic consumption