Clinical trial NCT05536063: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Cardiac Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
timeFrame: Postoperative pain assessment is performed using FLACC pain scale at fixed time intervasl for 48 hours post extubation,
Secondary outcomes:
measure: total analgesic consumption postoperative
timeFrame: for 48 hours postextubation
Other outcomes:
measure: Beta endorphins levels
timeFrame: Blood samples for postoperative beta-endorphins at 2, 24, and 48 hours post-extubation
Locations:
Study officials:
References:
citation: 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.
citation: 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.