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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 75
- Primary Endpoint
- postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 2 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
group A
bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side
Intervention: bilateral erector spinae plane block in pediatric cardiac surgeries (Procedure)
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
Intervention: bilateral erector spinae plane block in pediatric cardiac surgeries (Procedure)
Group C
control group will receive the standard analgesic regimen only
Outcomes
Primary Outcomes
postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
Time Frame: 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 Outcomes
- total analgesic consumption postoperative(for 48 hours postextubation)
Investigators
Amonios khalil
assistant lecturer at anaesthesia and ICU department
Assiut University