Pediatric Pectointercostal and ESP Block
1 other identifier
interventional
60
1 country
1
Brief Summary
American Society of Anaesthesiologist physical status II-III, aged between 2, 12 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks. 2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2022
CompletedFirst Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedApril 27, 2023
October 1, 2022
10 months
October 18, 2022
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Postoperative analgesia
Postoperative analgesia will asses Face, Legs, Activity, Cry, Consolability (FLACC) score in (Postanesthesia care unit) PACU till the 24th hours postoperatively. FLACC score reflects pain score between 0-10. 0 means zero pain, 10 means worse pain score
24 hours in Postanesthesia care unit (PACU)
Postoperative morphine consumption
Postoperative morphine consumption will record till the postoperative 24 th hours
24 hours in Postanesthesia care unit (PACU)
Secondary Outcomes (1)
Postoperative agitation
First 24 hours at Postanesthesia care unit (PACU)
Study Arms (2)
Pectointercostal and ESP block
ACTIVE COMPARATORPectointercostal and ESP block will apply to the children after intubation. Totally bupivacain %0.25, 2.5 mg/kg will apply.
No Block
PLACEBO COMPARATORNo block will apply to the patient
Interventions
Both Pectointercostal at between 4th and 5th costa and ESP block will apply at thoracal 6 level to the patient.
Eligibility Criteria
You may qualify if:
- Ages between 2-12 years
- ASA II-III children
- The children who undergoing open heart surgery
You may not qualify if:
- Coagulopaty
- Allergy of local anesthetic
- Liver and renal failure
- Obesity (BMI \>35kg/m2)
- Infection at the block area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University
Adana, 01380, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ebru Biricik
Cukurova University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 18, 2022
First Posted
October 21, 2022
Study Start
October 15, 2022
Primary Completion
August 15, 2023
Study Completion
August 15, 2023
Last Updated
April 27, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share