Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Pain Score [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]
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.
Secondary Outcome Measures
- peroperative opioid consumption [during operation]
sum of fentanyl and remifentanil consumption in micrograms
- Postoperative opioid consumption [From extubation to 24 hours after extubation.]
morphine usage in milligrams
- dexmedetomidine consumption [From the beginning of dexmedetomidine infusion to 24 hours after extubation]
dexmedetomidine in micrograms
- Paracetamol consumption [From extubation to 24 hours after extubation.]
paracetamol in milligrams
Other Outcome Measures
- extubation time [up to 24 hours]
time of extubation in hours
- intensive care stay [up to 24 weeks]
length of intensive care stay in days
- hospital stay [up to 1 year]
hospital stay in days
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass.
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age between 6 months and 12 years
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ASA score 2 or 3
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Risk Adjustment for Congenital Heart Surgery (RACHS-1) score under 4
Exclusion Criteria:
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patients who need mechanical ventilation support before surgery
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patients who need to stay intubated more than 24 hours after surgery
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patients undergo complex cardiac surgery with RACHS-1 score higher than 4.
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patients without consent
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having allergic reaction to bupivacaine
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having cardiac surgery before (redo patient)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Basaksehir Cam and Sakura City Hospital | Istanbul | Basaksehir | Turkey | 34480 |
Sponsors and Collaborators
- Basaksehir Cam & Sakura Şehir Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KAEK/2022.01.21