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NCT05142176

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

Status unknown NA Last updated 1 February 2022
What this trial tests

NA trial testing Erector spinae catheters insertion in Cardiac Surgery in 75 participants. Status unknown.

Timeline
5 February 2022
Primary endpoint
30 March 2022
30 March 2022

Quick facts

Lead sponsorTanta University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment75
Start date5 February 2022
Primary completion30 March 2022
Estimated completion30 March 2022

Drugs / interventions tested

Conditions studied

Sponsor

Tanta University

Who can join

Adults 3 to 12, any sex, with Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Bilateral Ultrasound-Guided Erector Spinae Plane Block for Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy.
    Mogahed MM, Abd El-Ghaffar MS, Elkahwagy MS. · · 2024 · cited 7× · PMID 39365129 · DOI 10.4103/aca.aca_210_23

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Other recruiting trials for Cardiac Surgery

Currently open trials in the same condition.

Other Tanta University trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05142176.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing