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Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

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ClinicalTrials.gov Identifier: NCT02715999
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Gözen Öksüz, Kahramanmaras Sutcu Imam University

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Quadratus Lumborum Block Procedure: Transversus Abdominis Plane Block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics
Study Start Date : February 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Quadratus Lumborum Block
Quadratus Lumborum block group (QL) patients will receive unilaterally Quadratus Lumborum block using Bupivacaine 0.2 %
Procedure: Quadratus Lumborum Block
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
Other Name: QLB

Active Comparator: Transversus abdominis plane block
Transversus abdominis plane block (TAP) patients will receive unilaterally TAP block using Bupivacaine 0.2 %
Procedure: Transversus Abdominis Plane Block
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.
Other Name: TAP




Primary Outcome Measures :
  1. time to first use of analgesic [ Time Frame: 24 hour ]
    By investigators until hospital discharge, then through telephone interview with parents after that


Secondary Outcome Measures :
  1. Total paracetamol consumption [ Time Frame: 24 hour ]
    By investigators until hospital discharge, then through telephone interview with parents after that

  2. Parent satisfaction scores [ Time Frame: 24 hour ]
    By investigators until hospital discharge, then through telephone interview with parents after that

  3. FLACC (face, legs, activity, cry, consolability) [ Time Frame: 1,2,4,6,12,24 hour ]
    By investigators until hospital discharge, then through telephone interview with parents after that



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715999


Locations
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Turkey
Kahramanmaras Sutcu Imam University Hospital
Kahramanmaras, Turkey
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Principal Investigator: Gözen Öksüz, M.D. Kahramanmaras Sutcu Imam University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gözen Öksüz, Associate Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT02715999    
Other Study ID Numbers: 05-02/2016
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations