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Pediatric Pectointercostal and ESP Block

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Pectointercostal and ESP block
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pectointercostal and ESP block

No Block

Arm Description

Pectointercostal and ESP block will apply to the children after intubation. Totally bupivacain %0.25, 2.5 mg/kg will apply.

No block will apply to the patient

Outcomes

Primary Outcome Measures

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
Postoperative morphine consumption
Postoperative morphine consumption will record till the postoperative 24 th hours

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2022
Last Updated
April 26, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05590026
Brief Title
Pediatric Pectointercostal and ESP Block
Official Title
Pediatric Pectointercostal and ESP Block in Cardiac Surgery Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pectointercostal and ESP block
Arm Type
Active Comparator
Arm Description
Pectointercostal and ESP block will apply to the children after intubation. Totally bupivacain %0.25, 2.5 mg/kg will apply.
Arm Title
No Block
Arm Type
Placebo Comparator
Arm Description
No block will apply to the patient
Intervention Type
Drug
Intervention Name(s)
Pectointercostal and ESP block
Other Intervention Name(s)
Fascia plane blocks
Intervention Description
Both Pectointercostal at between 4th and 5th costa and ESP block will apply at thoracal 6 level to the patient.
Primary Outcome Measure Information:
Title
Postoperative analgesia
Description
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
Time Frame
24 hours in Postanesthesia care unit (PACU)
Title
Postoperative morphine consumption
Description
Postoperative morphine consumption will record till the postoperative 24 th hours
Time Frame
24 hours in Postanesthesia care unit (PACU)
Secondary Outcome Measure Information:
Title
Postoperative agitation
Description
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.
Time Frame
First 24 hours at Postanesthesia care unit (PACU)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Biricik
Phone
+905052420223
Email
ebrubiricik01@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Biricik
Phone
+903223386084
Email
ebrubiricik01@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Biricik
Organizational Affiliation
Çukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebru Biricik, MD
Phone
05052420223
Email
ebrubiricik01@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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