Pediatric Pectointercostal and ESP Block

Pediatric Pectointercostal and ESP Block in Cardiac Surgery Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Pectointercostal and ESP block

Detailed Description

American Society of Anaesthesiologist physical status II-III, aged between 2-12, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block and block will not perform to the control group. Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks.2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores. FLACC, Watcha scores, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the FLACC score is higher than 4, morphine 0.015 mg/kg will administer intravenously.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ebru Biricik; Phone Number: +905052420223; Email: ebrubiricik01@gmail.com
• Study Contact Backup: Name: Ebru Biricik; Phone Number: +903223386084; Email: ebrubiricik01@gmail.com

Study Locations

• Turkey
  • Adana, Turkey, 01380
    • Recruiting
    • Cukurova University
    • Contact: Ebru Biricik, MD; Phone Number: 05052420223; Email: ebrubiricik01@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages between 2-12 years
• ASA II-III children
• The children who undergoing open heart surgery

Exclusion Criteria:

• Coagulopaty
• Allergy of local anesthetic
• Liver and renal failure
• Obesity (BMI >35kg/m2)
• Infection at the block area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pectointercostal and ESP block; Pectointercostal and ESP block will apply to the children after intubation. Totally bupivacain %0.25, 2.5 mg/kg will apply.	Drug: Pectointercostal and ESP block; Both Pectointercostal at between 4th and 5th costa and ESP block will apply at thoracal 6 level to the patient.; Other Names: Fascia plane blocks
Placebo Comparator: No Block; No block will apply to the patient	Drug: Pectointercostal and ESP block; Both Pectointercostal at between 4th and 5th costa and ESP block will apply at thoracal 6 level to the patient.; Other Names: Fascia plane blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative agitation	The patients will asses with Watcha score for postoperative agitation in Postanesthesia care unit (PACU) till the postoperative 24th hours. Watcha score reflects delirium score (scale between 0 to 4). A child with a score of >2 on the Watcha score can be considered to have emergence delirium. (Points between 0-4) Watcah is one of the author's name.	First 24 hours at Postanesthesia care unit (PACU)

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Ebru Biricik, Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): August 15, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Pediatric Pectointercostal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No