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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

A

Assiut University

Status

Not yet enrolling

Conditions

Pediatric Cardiac Surgery

Treatments

Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries

Study type

Interventional

Funder types

Other

Identifiers

NCT05536063
ESPB in ped. cardiac surgeries

Details and patient eligibility

About

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

Full 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

Enrollment

75 estimated patients

Sex

All

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

75 participants in 3 patient groups

group A
Experimental group
Description:
bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side
Treatment:
Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries
Group B
Experimental group
Description:
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
Treatment:
Procedure: bilateral erector spinae plane block in pediatric cardiac surgeries
Group C
No Intervention group
Description:
control group will receive the standard analgesic regimen only

Trial contacts and locations

0

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Central trial contact

Amonios khalil, assistan lecturer

Data sourced from clinicaltrials.gov

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