Clinical trial NCT06089798: Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery
Official title: Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Fascial Block in Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Regional Anesthesia
Keywords: pecto-intercostal fascial block
pediatric congenital cardiac surgery
postoperative pain management
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-18
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 6 months to 12 years old, undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass with ASA score 2 or 3.

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.


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

Primary outcomes:
measure: Pain Score
timeFrame: 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 outcomes:
measure: peroperative opioid consumption
timeFrame: during operation
measure: Postoperative opioid consumption
timeFrame: From extubation to 24 hours after extubation.
measure: dexmedetomidine consumption
timeFrame: From the beginning of dexmedetomidine infusion to 24 hours after extubation
measure: Paracetamol consumption
timeFrame: From extubation to 24 hours after extubation.
Other outcomes:
measure: extubation time
timeFrame: up to 24 hours
measure: intensive care stay
timeFrame: up to 24 weeks
measure: hospital stay
timeFrame: up to 1 year
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam and Sakura City Hospital
state: Basaksehir
Study officials:
References: