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Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quadratus lumborum block
Caudal 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)All SexesDoes 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

    1. renal
    2. hepatic
    3. cardiac
    4. upper or lower airway
    5. neurological

Sites / Locations

  • KahramanmarasSIU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus Lumborum block group

Caudal 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. Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.7 ml/kg bupivacaine 0.25 % injected unilaterally at the posterior border of the quadratus lumborum muscle.

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 caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.

Outcomes

Primary Outcome Measures

Use of analgesic consumption
paracetamol

Secondary Outcome Measures

Flacc score( face, legs, activity, cry, consolability)
By investigators until hospital discharge, then through telephone interview with parents after that
Parent satisfaction scores
By investigators until hospital discharge, then through telephone interview with parents after that
Time to first use of analgesic
By investigators until hospital discharge, then through telephone interview with parents after that

Full Information

First Posted
September 22, 2017
Last Updated
November 15, 2018
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT03294291
Brief Title
Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient
Official Title
Quadratus Lumborum Block Versus Caudal Block
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam 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 low abdominal surgery. Investigators will perform two technique;Caudal block or Quadratus lumborum block .The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method. The results of this study will help learn how to best control pain in children having surgery low abdominal surgery.
Detailed Description
Children aged 1-9 years undergoing lower abdominal 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 unilaterally low abdominal surgery(inguinal hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus lumborum 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 and Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) 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 25 patients each using a computer-generated number table.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum block group
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. Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.7 ml/kg bupivacaine 0.25 % injected unilaterally at the posterior border of the quadratus lumborum muscle.
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 caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block
Intervention Description
Postoperative pain procedure
Intervention Type
Procedure
Intervention Name(s)
Caudal block
Intervention Description
Postoperative pain procedure
Primary Outcome Measure Information:
Title
Use of analgesic consumption
Description
paracetamol
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Flacc score( face, legs, activity, cry, consolability)
Description
By investigators until hospital discharge, then through telephone interview with parents after that
Time Frame
1,2,4,6,12,24 hou
Title
Parent satisfaction scores
Description
By investigators until hospital discharge, then through telephone interview with parents after that
Time Frame
24 hour
Title
Time to first use of analgesic
Description
By investigators until hospital discharge, then through telephone interview with parents after that
Time Frame
24 hour

10. Eligibility

Sex
All
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 neurological
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gözen Öksüz, M.D.
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KahramanmarasSIU
City
Kahramanmaraş
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28759502
Citation
Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
Results Reference
result
PubMed Identifier
31907294
Citation
Oksuz G, Arslan M, Urfalioglu A, Guler AG, Teksen S, Bilal B, Oksuz H. Comparison of quadratus lumborum block and caudal block for postoperative analgesia in pediatric patients undergoing inguinal hernia repair and orchiopexy surgeries: a randomized controlled trial. Reg Anesth Pain Med. 2020 Mar;45(3):187-191. doi: 10.1136/rapm-2019-101027. Epub 2020 Jan 5.
Results Reference
derived

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Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

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