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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Pediatric Cardiac Surgery

Intervention / Treatment
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* Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>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<br>* 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<br>|
| Experimental: Group B<br>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<br>* 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<br>|
| No Intervention: Group C<br>control group will receive the standard analgesic regimen only | |

What is the study measuring?
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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 |