Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06089798
Enrollment
82
Registered
2023-10-18
Start date
2023-11-01
Completion date
2025-11-01
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Anesthesia

Keywords

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

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.

Interventions

None listed

Sponsors

Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
Pain Scoreat the time of extubation, 1st hour after extubation, 2nd hour after extubation, 6th hour after extubation, 12th hour after extubation, 24th hour after extubationFace, 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.

Secondary

MeasureTime frameDescription
peroperative opioid consumptionduring operationsum of fentanyl and remifentanil consumption in micrograms
Paracetamol consumptionFrom extubation to 24 hours after extubation.paracetamol in milligrams
Postoperative opioid consumptionFrom extubation to 24 hours after extubation.morphine usage in milligrams
dexmedetomidine consumptionFrom the beginning of dexmedetomidine infusion to 24 hours after extubationdexmedetomidine in micrograms

Other

MeasureTime frameDescription
intensive care stayup to 24 weekslength of intensive care stay in days
hospital stayup to 1 yearhospital stay in days
extubation timeup to 24 hourstime of extubation in hours

Countries

Turkey (Türkiye)

Contacts

Primary Contactselin sağlam
selinsaglams@gmail.com0905557198756

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026