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

Recruiting

• Conditions: Regional Anesthesia

• Registration Number: NCT06089798
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-11
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Study Start: 2023-11-01
• Primary Completion: 2024-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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 4.
• patients without consent
• having allergic reaction to bupivacaine
• having cardiac surgery before (redo patient)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Score	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 Outcome Measures

Name	Time	Method
Postoperative opioid consumption	From extubation to 24 hours after extubation.	morphine usage in milligrams
Paracetamol consumption	From extubation to 24 hours after extubation.	paracetamol in milligrams
peroperative opioid consumption	during operation	sum of fentanyl and remifentanil consumption in micrograms
dexmedetomidine consumption	From the beginning of dexmedetomidine infusion to 24 hours after extubation	dexmedetomidine in micrograms

Trial Locations

Locations (1)

Basaksehir Cam and Sakura City Hospital; 🇹🇷 Istanbul, Basaksehir, Turkey