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Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quadratus Lumborum Block
Transversus Abdominis Plane Block
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria:

  • ASA physical status I-II
  • undergoing unilateral low abdominal surgery

Exclusion Criteria:

  • history of allergic reactions to local anesthetics
  • rash or infection at the injection site
  • anatomical abnormality
  • bleeding diatheses, coagulopathy, liver diseases

Sites / Locations

  • Kahramanmaras Sutcu Imam University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus Lumborum Block

Transversus abdominis plane block

Arm Description

Quadratus Lumborum block group (QL) patients will receive unilaterally Quadratus Lumborum block using Bupivacaine 0.2 %

Transversus abdominis plane block (TAP) patients will receive unilaterally TAP block using Bupivacaine 0.2 %

Outcomes

Primary Outcome Measures

time to first use of analgesic
By investigators until hospital discharge, then through telephone interview with parents after that

Secondary Outcome Measures

Total paracetamol consumption
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
FLACC (face, legs, activity, cry, consolability)
By investigators until hospital discharge, then through telephone interview with parents after that

Full Information

First Posted
March 13, 2016
Last Updated
November 28, 2017
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT02715999
Brief Title
Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics
Official Title
Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

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 of trunk block; Transversus abdominis plane 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 1-7 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 Transversus abdominis plane block at the begin of surgery. All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. The spread of injectate will be seed on ultrasound.The dose of local anaesthetic in both groups will be 0.5 ml/kg 0.2 % Bupivacaine. Anesthesia would be maintained with 2% sevoflurane An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose 5% (1:1) solution was infused in a dose of 12 ml/ kg /h. 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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum Block
Arm Type
Active Comparator
Arm Description
Quadratus Lumborum block group (QL) patients will receive unilaterally Quadratus Lumborum block using Bupivacaine 0.2 %
Arm Title
Transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
Transversus abdominis plane block (TAP) patients will receive unilaterally TAP block using Bupivacaine 0.2 %
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block
Other Intervention Name(s)
QLB
Intervention 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.All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally at the posterior border of the quadratus lumborum muscle
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block
Other Intervention Name(s)
TAP
Intervention 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. All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally between internal oblique and transversus abdominis muscles.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Total paracetamol consumption
Description
By investigators until hospital discharge, then through telephone interview with parents after that
Time Frame
24 hour
Title
Parent satisfaction scores
Description
By investigators until hospital discharge, then through telephone interview with parents after that
Time Frame
24 hour
Title
FLACC (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 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: ASA physical status I-II undergoing unilateral low abdominal surgery Exclusion Criteria: history of allergic reactions to local anesthetics rash or infection at the injection site anatomical abnormality bleeding diatheses, coagulopathy, liver diseases
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
Kahramanmaras Sutcu Imam University Hospital
City
Kahramanmaras
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26225500
Citation
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
Results Reference
background
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
derived

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Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

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