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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05536063
Enrollment
75
Registered
2022-09-10
Start date
2023-05-31
Completion date
2025-05-31
Last updated
2022-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cardiac Surgery

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

Interventions

PROCEDUREbilateral erector spinae plane block in pediatric cardiac surgeries

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scalePostoperative 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

MeasureTime frameDescription
total analgesic consumption postoperativefor 48 hours postextubationtotal amount of postoperative analgesic consumption

Other

MeasureTime frameDescription
Beta endorphins levelsBlood samples for postoperative beta-endorphins at 2, 24, and 48 hours post-extubationcomparison between preoperative and postoperative levels of B-endorphins

Contacts

Primary ContactAmonios khalil, assistan lecturer
amonios_khalil@yahoo.com01023466456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026