Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery
NCT ID: NCT06089798
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
82 participants
OBSERVATIONAL
2023-11-01
2025-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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PIFB Group
The patients in this group will be applied pecto-intercostal fascial block before surgical incision additional to general anesthesia.
No interventions assigned to this group
Nonblock Group
The patients in this group will be given only standard general anesthesia.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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)
6 Months
12 Years
ALL
No
Sponsors
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Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Selin Saglam
Principal Investigator
Locations
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Basaksehir Cam and Sakura City Hospital
Istanbul, Basaksehir, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KAEK/2022.01.21
Identifier Type: -
Identifier Source: org_study_id
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