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

NCT06089798 | Unknown

• 1 other identifier: KAEK/2022.01.21
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia

Keywords

pecto-intercostal fascial block; pediatric congenital cardiac surgery; postoperative pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• peroperative opioid consumption

  during operation

• Postoperative opioid consumption

  From extubation to 24 hours after extubation.

• dexmedetomidine consumption

  From the beginning of dexmedetomidine infusion to 24 hours after extubation

• Paracetamol consumption

  From extubation to 24 hours after extubation.

Other Outcomes (3)

• extubation time

  up to 24 hours

• intensive care stay

  up to 24 weeks

• hospital stay

  up to 1 year

Study Arms (2)

PIFB Group

The patients in this group will be applied pecto-intercostal fascial block before surgical incision additional to general anesthesia.

Nonblock Group

The patients in this group will be given only standard general anesthesia.

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

RECRUITING

Central Study Contacts

selin sağlam

CONTACT

0905557198756; selinsaglams@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: October 18, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

TU (1)