Skip to main content
Clinical Trials/NCT06089798
NCT06089798
Recruiting
Not Applicable

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

Başakşehir Çam & Sakura City Hospital1 site in 1 country82 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Regional Anesthesia
Sponsor
Başakşehir Çam & Sakura City Hospital
Enrollment
82
Locations
1
Primary Endpoint
Pain Score
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
November 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Başakşehir Çam & Sakura City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Selin Saglam

Principal Investigator

Başakşehir Çam & Sakura City Hospital

Eligibility Criteria

Inclusion Criteria

  • patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and 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 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
  • patients without consent
  • having allergic reaction to bupivacaine
  • having cardiac surgery before (redo patient)

Outcomes

Primary Outcomes

Pain Score

Time Frame: at the time of extubation, 1st hour after extubation, 2nd hour after extubation, 6th hour after extubation, 12th hour after extubation, 24th hour after extubation

Face, Legs, Activity, Cry, Consolability scale (FLACC scale), FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. The values are between 0 and 10. The higher the score the worse the pain and outcome.

Secondary Outcomes

  • Postoperative opioid consumption(From extubation to 24 hours after extubation.)
  • Paracetamol consumption(From extubation to 24 hours after extubation.)
  • peroperative opioid consumption(during operation)
  • dexmedetomidine consumption(From the beginning of dexmedetomidine infusion to 24 hours after extubation)

Study Sites (1)

Loading locations...

Similar Trials