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

Study Overview
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Brief Summary
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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.

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

Conditions
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Regional Anesthesia

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PIFB Group<br>The patients in this group will be applied pecto-intercostal fascial block before surgical incision additional to general anesthesia. | |
| Nonblock Group<br>The patients in this group will be given only standard general anesthesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peroperative opioid consumption | sum of fentanyl and remifentanil consumption in micrograms | during operation | 
| Postoperative opioid consumption | morphine usage in milligrams | From extubation to 24 hours after extubation. | 
| dexmedetomidine consumption | dexmedetomidine in micrograms | From the beginning of dexmedetomidine infusion to 24 hours after extubation | 
| Paracetamol consumption | paracetamol in milligrams | From extubation to 24 hours after extubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pecto-intercostal fascial block, pediatric congenital cardiac surgery, postoperative pain management