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Bilateral Erector Spinae Plane Block for Management of Acute Postoperative Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy

NCT05142176 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-02-01

No results posted yet for this study

Summary

Many analgesic modalities have been investigated in pediatrics. The analgesic efficacy of bilateral ultrasound-guided erector spinae plane block in pediatric patients undergoing open midline sternotomy will be examined. Methods: 60 patients aged 3- 12 years will be randomly assigned into two groups: Control group will receive general anesthesia with bilateral sham erector spinae plane block at the level of T6 transverse process using 0.3 ml/kg normal saline on each side. Erector spinae plane block group will receive bilateral ultrasound-guided erector spinae plane block at the level of T6 transverse process using 0.3 ml/kg bupivacaine 0.25% (on each side) with a maximum dose of 2 mg/kg. The postoperative pain was assessed using Modified Objective Pain Scores (MOPS) which will be evaluated at 0, 1, 2, 4, 6, 8, 10, and 12 hours after extubation, total consumption of intraoperative fentanyl (1µg/kg IV in case of inadequate analgesia), time to first rescue analgesic administration and postoperative paracetamol consumption will be recorded over the first 24 hours postoperatively.

Conditions

  • Cardiac Surgery

Interventions

OTHER

Erector spinae catheters insertion

Ultrasound-Guided ESPB The ESPB will be performed with the child in a right lateral decubitus position under aseptic precautions by a high frequency (6-13 MHz) linear ultrasound transducer

DRUG

Postoperative pain management

IV acetaminophen 15 mg/kg every 8 hours as a component of multimodal analgesia.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-05
Primary Completion
2022-03-30
Completion
2022-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05142176 on ClinicalTrials.gov