drugset / Trial / NCT06873906

Deep Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Patients Undergoing Primary Repair of Septal Defects Via Median Sternotomy

NCT06873906

Phase 3 Not yet recruiting 45 enrolled Ain Shams University
RandomizedParallel-groupTriple-blindTreatment

Summary

In this study we are aiming to compare the Erector Spinae Plane Block and the Deep Parasternal intercostal plane block as regard to their technique, application and outcome in order to describe the most suitable method for pediatric cardiac patients undergoing primary repair of septal defects The primary outcome of this study will be the time of the first request for postoperative analgesics by FLACC pain scale more than 4 The secondary outcomes will be the total postoperative analgesic consumption, time for extubation, the incidence of nausea and vomiting, hemodynamic instability, onset of ambulation and any other complications on the first day after surgery Participants will be enrolled in this double-blinded randomly allocated using computer-based randomization into three groups. Group 1 will receive bilateral deep parasternal intercostal plane block. Group 2 will receive bilateral erector spinae plane block. Group 3 will receive conventional analgesic regimen without having a regional block

Timeline

Start
2025-03-20
Primary completion
2026-03-20
Completion
2026-04-01

Drugs

EvaluationDrugModalityDoseRoute
Background Bupivacaine Other / unclassified 2 mg/kg
Comparator Fentanyl Other / unclassified 1 ug/kg Intravenous
Comparator Isoflurane Other / unclassified
Comparator Ketamine Small molecule 2 mg/kg Intravenous
Comparator Rocuronium Other / unclassified 0.15 mg/kg Intravenous

Indications