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Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Quadratus Lumborum Block
Bupivacaine (Block Drug)
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Pediatric Surgery, Postoperative Pain, Erector spinae plane block, quadratus lumborum block

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1-7 years of age
  • ASA I-II
  • Undergoing elective low abdominal surgery

Exclusion Criteria:

  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • ASA III-IV
  • Patients with neurological disorders

Sites / Locations

  • Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESP Group

QLB Group

Arm Description

Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

Quadratus Lumborum Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

Outcomes

Primary Outcome Measures

Pain scores
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.

Secondary Outcome Measures

Time to first analgesic drug
Time to first analgesic drug will be recorded
Need for analgesic
Number of patients who required analgesic in the first 24 hour

Full Information

First Posted
February 28, 2018
Last Updated
November 12, 2018
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT03463382
Brief Title
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children
Official Title
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran 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
Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pediatric Surgery, Postoperative Pain, Erector spinae plane block, quadratus lumborum block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP Group
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks
Arm Title
QLB Group
Arm Type
Active Comparator
Arm Description
Quadratus Lumborum Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
Erector Spinae Plane block will be administered under general anesthesia before the surgery
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block
Intervention Description
Quadratus Lumborum Block will be administered under general anesthesia before the surgery
Intervention Type
Drug
Intervention Name(s)
Bupivacaine (Block Drug)
Intervention Description
0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances
Primary Outcome Measure Information:
Title
Pain scores
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.
Time Frame
Postoperative first 6hours
Secondary Outcome Measure Information:
Title
Time to first analgesic drug
Description
Time to first analgesic drug will be recorded
Time Frame
first 48 hour
Title
Need for analgesic
Description
Number of patients who required analgesic in the first 24 hour
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1-7 years of age ASA I-II Undergoing elective low abdominal surgery Exclusion Criteria: infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy ASA III-IV Patients with neurological disorders
Facility Information:
Facility Name
Kocaeli University Hospital
City
İzmit
State/Province
Kocaeli
ZIP/Postal Code
41340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30851499
Citation
Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
Results Reference
derived

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Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children

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