Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery

Last updated: October 17, 2023
Sponsor: Basaksehir Cam & Sakura Şehir Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia (Local)

Anesthesia

Treatment

N/A

Clinical Study ID

NCT06089798
KAEK/2022.01.21
  • Ages 6-12
  • All Genders

Study Summary

The goal of this study is to compare patients outcome in two groups. the first group will be applied pecto-intercostal fascial block additional to general anesthesia and the second group will not.

This is a single-center, prospective, observational trial to study the efficacy of Pecto-intercostal Fascial Block (PIFB) in patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass. The children are aged between 6 months to 12 years with American Society of Anesthesiologists (ASA) score 2 or 3.

The main question it aims to answer are:

The investigators' first question is if applying pecto-intercostal fascial block just after anesthesia induction reduces postoperative pain status. Secondly, if this pain status makes any reduction in preoperative opioid consumption. The investigators aim to find out; if there is any difference in opioid consumption during operation and postoperative 24-hour, postoperative Face, Legs, Activity, Cry, Consolability (FLACC) scale, length of intensive care unit and hospital stays, and other complications.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients undergoing pediatric congenital cardiac surgery requiring median sternotomyand cardiopulmonary bypass.
  • age between 6 months and 12 years
  • ASA score 2 or 3
  • Risk Adjustment for Congenital Heart Surgery (RACHS-1) score under 4

Exclusion

Exclusion Criteria:

  • patients who need mechanical ventilation support before surgery
  • patients who need to stay intubated more than 24 hours after surgery
  • patients undergo complex cardiac surgery with RACHS-1 score higher than 4.
  • patients without consent
  • having allergic reaction to bupivacaine
  • having cardiac surgery before (redo patient)

Study Design

Total Participants: 82
Study Start date:
November 01, 2023
Estimated Completion Date:
November 01, 2025

Connect with a study center

  • Basaksehir Cam and Sakura City Hospital

    Istanbul, Basaksehir 34480
    Turkey

    Active - Recruiting

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