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Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

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ClinicalTrials.gov Identifier: NCT03294291
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : November 16, 2018
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;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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Quadratus lumborum block Procedure: Caudal block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All Children will be randomly assigned to one of 2 groups of 25 patients each using a computer-generated number table.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Block Versus Caudal Block
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : November 15, 2018

Arm Intervention/treatment
Active Comparator: Quadratus Lumborum block group
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.
Procedure: Quadratus lumborum block
Postoperative pain procedure

Active Comparator: Caudal 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 caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.
Procedure: Caudal block
Postoperative pain procedure




Primary Outcome Measures :
  1. Use of analgesic consumption [ Time Frame: 24 hour ]
    paracetamol


Secondary Outcome Measures :
  1. Flacc score( face, legs, activity, cry, consolability) [ Time Frame: 1,2,4,6,12,24 hou ]
    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. Time to first use of analgesic [ Time Frame: 24 hour ]
    By investigators until hospital discharge, then through telephone interview with parents after that



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Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03294291


Locations
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Turkey
KahramanmarasSIU
Kahramanmaraş, Turkey
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Principal Investigator: Gözen Öksüz, M.D. Kahramanmaras Sutcu Imam University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gözen Öksüz, Assistant Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT03294291    
Other Study ID Numbers: 2017/10-08
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations