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

Regional Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089798
• Other study ID #: KAEK/2022.01.21
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2023
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: selin saglam
• Phone: 0905557198756
• Email: selinsaglams[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Regional Anesthesia

Locations

Country	Name	City	State
Turkey	Basaksehir Cam and Sakura City Hospital	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	extubation time	time of extubation in hours	up to 24 hours
Other	intensive care stay	length of intensive care stay in days	up to 24 weeks
Other	hospital stay	hospital stay in days	up to 1 year
Primary	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	peroperative opioid consumption	sum of fentanyl and remifentanil consumption in micrograms	during operation
Secondary	Postoperative opioid consumption	morphine usage in milligrams	From extubation to 24 hours after extubation.
Secondary	dexmedetomidine consumption	dexmedetomidine in micrograms	From the beginning of dexmedetomidine infusion to 24 hours after extubation
Secondary	Paracetamol consumption	paracetamol in milligrams	From extubation to 24 hours after extubation.