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Comparison Sacral Erector Spinae Block Versus Caudal Block

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound Guided Caudal Block
Sacral Erector Spinae Block
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

1 Year - 9 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 1-9
  2. ASA physical status I-II
  3. Undergoing unilateral low abdominal surgery

Exclusion Criteria:

  1. History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
  2. Parent refusal
  3. History of allergic reactions to local anesthetics
  4. Rash or infection at the injection site
  5. Anatomical abnormality
  6. Bleeding diatheses
  7. Coagulopathy
  8. History of diseases renal hepatic cardiac upper or lower airway neurologica

Sites / Locations

  • Koç University Hospital
  • Kahramanmaras Sutcu Imam University Hospital
  • Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caudal Block

Sacral Erector Spinae Block

Arm Description

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided caudal block wil performe with bupivacaine 1 ml/kg as 0.25%.

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided sacral erector spinae block wil performe with bupivacaine 1 ml/kg as 0.25%.

Outcomes

Primary Outcome Measures

Number of analgesic consumption
Acetaminophen and Fentanly

Secondary Outcome Measures

Face, Legs, Activity, Cry and Consolability Score (FLACC)
FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. FLACC scale will be recorded at postoperative 30 minute, 1,2,4,6,12,24 hour
Parent satisfaction scores
By investigators until hospital discharge, then through telephone interview with parents after that. Will be scored between 1-3 (1- very bad, 2-good, 3-very good).

Full Information

First Posted
September 25, 2019
Last Updated
February 29, 2020
Sponsor
Kahramanmaras Sutcu Imam University
Collaborators
Kirsehir Ahi Evran University, Koç University
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1. Study Identification

Unique Protocol Identification Number
NCT04106687
Brief Title
Comparison Sacral Erector Spinae Block Versus Caudal Block
Official Title
A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University
Collaborators
Kirsehir Ahi Evran University, Koç University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this research study is to find the best way to decrease pain in children whom have had hypospadias surgery. Investigators will perform two technique; Caudal block or Sacral erector spinae block. The results of this study will help learn how to best control pain in children having surgery hypospadias surgery.
Detailed Description
Children aged 1-9 years undergoing hypospadias surgeries would be recruited in this randomized study. Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure. After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval, informed written consent will be obtained from all patients. Consenting patients scheduled to have hypospadias surgery will be randomised to sacral erector spinae block or caudal block at the begin of surgery. All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will receive paracetamol if requirement for postoperative analgesia.All patient will transfer from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten. All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC score will be used.

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
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caudal Block
Arm Type
Active Comparator
Arm Description
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided caudal block wil performe with bupivacaine 1 ml/kg as 0.25%.
Arm Title
Sacral Erector Spinae Block
Arm Type
Active Comparator
Arm Description
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided sacral erector spinae block wil performe with bupivacaine 1 ml/kg as 0.25%.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Caudal Block
Intervention Description
Postoperative pain procedure
Intervention Type
Procedure
Intervention Name(s)
Sacral Erector Spinae Block
Intervention Description
Postoperative pain procedure
Primary Outcome Measure Information:
Title
Number of analgesic consumption
Description
Acetaminophen and Fentanly
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Face, Legs, Activity, Cry and Consolability Score (FLACC)
Description
FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. FLACC scale will be recorded at postoperative 30 minute, 1,2,4,6,12,24 hour
Time Frame
24 hour
Title
Parent satisfaction scores
Description
By investigators until hospital discharge, then through telephone interview with parents after that. Will be scored between 1-3 (1- very bad, 2-good, 3-very good).
Time Frame
24 hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 1-9 ASA physical status I-II Undergoing unilateral low abdominal surgery Exclusion Criteria: History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult Parent refusal History of allergic reactions to local anesthetics Rash or infection at the injection site Anatomical abnormality Bleeding diatheses Coagulopathy History of diseases renal hepatic cardiac upper or lower airway neurologica
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Can Aksu, M.D.
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yavuz Gürkan, Professor
Organizational Affiliation
Koç University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koç University Hospital
City
İstanbul
Country
Turkey
Facility Name
Kahramanmaras Sutcu Imam University Hospital
City
Kahramanmaras
Country
Turkey
Facility Name
Kocaeli University Hospital
City
Kocaeli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31491727
Citation
Oksuz G, Arslan M, Bilal B, Gisi G, Yavuz C. Ultrasound guided sacral erector spinae block for postoperative analgesia in pediatric anoplasty surgeries. J Clin Anesth. 2020 Mar;60:88. doi: 10.1016/j.jclinane.2019.08.006. Epub 2019 Sep 3. No abstract available.
Results Reference
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PubMed Identifier
31203111
Citation
Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.
Results Reference
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Comparison Sacral Erector Spinae Block Versus Caudal Block

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