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Effect Posterior QLB on Atelectasis

Primary Purpose

Atelectasis, Block, Pediatrics

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
posterior quadratus lumborum block
Sponsored by
Zonguldak Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring postoperative atelectasis, ultrasound, lung ultrasound score, posterior QLB

Eligibility Criteria

0 Years - 2 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • under 2 years old,
  • ASA I-II risk group
  • Patients who underwent an inguinal hernia operation under general anesthesia, posterior quadratus lumborum block for postoperative analgesia or pain treatment with conventional method
  • Patients whose informed consent was read and approval was obtained from him and his guardian

Exclusion Criteria:

  • who do not want to participate in the study,
  • ASA III-IV-V patients

Sites / Locations

  • Zonguldak Bülent Ecevit University Medicine FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Posterior quadratus lumborum block

control group

Arm Description

Outcomes

Primary Outcome Measures

lung ultrasound score
atelectasis

Secondary Outcome Measures

pain scores
Flacc scores

Full Information

First Posted
March 29, 2021
Last Updated
June 1, 2021
Sponsor
Zonguldak Bulent Ecevit University
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1. Study Identification

Unique Protocol Identification Number
NCT04830280
Brief Title
Effect Posterior QLB on Atelectasis
Official Title
The Effect of Ultrasound-guided Posterior Quadratus Lumborum Block on Atelectasis in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zonguldak Bulent Ecevit 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
We aimed to investigate the effect of posterior quadratus lumborum block on postoperative atelectasis in inguinal hernia surgery in pediatric patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Block, Pediatrics, Quadratus Lumborum Block
Keywords
postoperative atelectasis, ultrasound, lung ultrasound score, posterior QLB

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Posterior quadratus lumborum block
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
posterior quadratus lumborum block
Intervention Description
administration local anesthetic solution between the middle layer of the thoracolumbar fascia and QL muscle at the posterior edge of the quadratus lumborum muscle
Primary Outcome Measure Information:
Title
lung ultrasound score
Description
atelectasis
Time Frame
up to 1 hour after surgery
Secondary Outcome Measure Information:
Title
pain scores
Description
Flacc scores
Time Frame
up to 6 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: under 2 years old, ASA I-II risk group Patients who underwent an inguinal hernia operation under general anesthesia, posterior quadratus lumborum block for postoperative analgesia or pain treatment with conventional method Patients whose informed consent was read and approval was obtained from him and his guardian Exclusion Criteria: who do not want to participate in the study, ASA III-IV-V patients
Facility Information:
Facility Name
Zonguldak Bülent Ecevit University Medicine Faculty
City
Zonguldak
State/Province
Kozlu
ZIP/Postal Code
67600
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
murat can
Phone
+90 372 261 20 01
Ext
2839
Email
murat.can@beun.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect Posterior QLB on Atelectasis

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