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Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT03646630
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Doaa Lotfy, Fayoum University Hospital

Brief Summary:
The aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Quadratus Lumborum Block Procedure: Caudal Block Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block for Pain Relief in Children Undergoing Lower Abdominal Surgeries
Estimated Study Start Date : May 2, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 15, 2019

Arm Intervention/treatment
Active Comparator: Quadratus Lumborum Block (QL)
Patients will be placed in the lateral position,The high-frequency linear probe will be placed on the lateral abdomen, slightly cephalic to the iliac crest. Once the QL muscle will be observed, the probe will be tilted slightly to the caudal direction, to show the largest slice of the QL muscle, to confirm its posterior aspect. A 22-G block needle (Stimuplex D, Braun, Hongo, Bunkyo-ku, and Tokyo) will be inserted in-plane, ~1 cm ventral to the probe. The needle tip will be advanced until it penetrates the posterior fascia of the QL muscle. A small amount of saline will be injected to confirm the correct position of the tip, between the QL muscle and the erector spinae and latissimus dorsi muscles (Posterior or QL block type 2), then a bolus of 0.5 ml/Kg bupivacaine 0.25% will be injected.
Procedure: Quadratus Lumborum Block
Posterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25%

Active Comparator: Caudal block (C)
After induction of general anesthesia, a lateral position is obtained with the upper hip flexed 90⁰ and the lower one only 45⁰. A line is drawn to connect the posterior superior iliac spines bilaterally and used as one side of an equilateral triangle; then the location of the sacral hiatus should be approximated. By palpating the sacral cornua as 2 bony prominences, the sacral hiatus could be identified as a dimple in between. A 22 gauge needle is inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted. Children will receive caudal block with 1 ml/kg of bupivacaine 0.25%.
Procedure: Caudal Block
caudal block with 1 ml/kg of bupivacaine 0.25%.




Primary Outcome Measures :
  1. Time at which the first analgesia required [ Time Frame: 24 hours after procedure ]
    in hours


Secondary Outcome Measures :
  1. Pain assessment by the aid of FLACC score [ Time Frame: 30 minutes after operation ]
    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  2. Pain assessment by the aid of FLACC score [ Time Frame: 1 hour after operation ]
    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  3. Pain assessment by the aid of FLACC score [ Time Frame: 2 hours after operation ]
    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  4. Pain assessment by the aid of FLACC score [ Time Frame: 4 hours after operation ]
    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  5. Pain assessment by the aid of FLACC score [ Time Frame: 6 hours after operation ]
    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  6. Pain assessment by the aid of FLACC score [ Time Frame: 12 hours after operation ]
    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  7. Pain assessment by the aid of FLACC score [ Time Frame: 24 hours after operation ]
    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  8. number of analgesic doses for each patient [ Time Frame: 24 hours after operation ]
    by oral paracetamol 30 mg/kg given by parents

  9. The general satisfaction score of parents [ Time Frame: 24 hours after operation ]
    measured on a 5-point scale of 1.Extremely dissatisfied 2.Dissatisfied 3.Not satisfied, nor dissatisfied 4.Satisfied 5.Completely satisfied.

  10. Preoperative heart rate [ Time Frame: 5 minutes before operation ]
    in beat per minutes measured by electrocardiogram

  11. Preoperative systolic blood pressure [ Time Frame: 5 minutes before operation ]
    in mm mercury measured by non-invasive blood pressure measurement

  12. Preoperative diastolic blood pressure [ Time Frame: 5 minutes before operation ]
    in mm mercury measured by non-invasive blood pressure measurement

  13. Intraoperative systolic blood pressure [ Time Frame: every 15 minutes till end of operation ]
    in mm mercury measured by non-invasive blood pressure measurement

  14. Intraoperative diastolic blood pressure [ Time Frame: every 15 minutes till end of operation ]
    in mm mercury measured by non-invasive blood pressure measurement

  15. Intraoperative heart rate [ Time Frame: every 15 minutes till end of operation ]
    in beat per minutes measured by electrocardiogram

  16. Incidence of hypotension [ Time Frame: within one hour of the intervention ]
    drop of blood pressure more than 20 % of baseline blood pressure

  17. Incidence of bradycardia [ Time Frame: Within one hour of the intervention ]
    Heart rate below 50 beat per minute by electrocardiogram

  18. Incidence of vascular puncture [ Time Frame: Within one hour of the intervention ]
    as signs of local anesthetics toxicity

  19. Incidence of convulsions [ Time Frame: Within one hour of the intervention ]
    as signs of local anesthetics toxicity

  20. Incidence of arrhythmias [ Time Frame: Within one hour of the intervention ]
    as signs of local anesthetics toxicity

  21. Incidence of paresthesia [ Time Frame: Within one hour of the intervention ]
    as signs of local anesthetics toxicity

  22. Incidence of hematoma formation [ Time Frame: Within one hour of the intervention ]
    Recorded under ultrasound guidance

  23. Incidence of injury to the underlying structures [ Time Frame: Within one hour of the intervention ]
    Injury to the liver or a viscous



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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:

  • Age 1-7 years
  • American Society of Anesthesiologists physical status I-II
  • Lower abdominal surgery

Exclusion Criteria:

  • History of developmental delay or mental retardation
  • Parent refusal
  • History of allergic reactions to local anesthetics
  • Rash or infection at the injection site
  • Anatomical abnormality
  • Bleeding disorders.
  • History of cardiac, neurological, renal, hepatic 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): NCT03646630


Contacts
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Contact: Doaa L Abd Elbaky, M.Sc 01004683785 ext 002 dr.doaalotfy@yahoo.com
Contact: Kareem M Nawwar, MD 01003878369 ext 002 drknawwar@yahoo.com

Locations
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Egypt
Fayoum University hospital Recruiting
Madīnat al Fayyūm, Faiyum Governorate, Egypt, 63514
Contact: Hany M Yassin, MD.    1111363602 ext +20    hmy00@fayoum.edu.eg   
Contact: Yasser S Mostafa, M.Sc.    1010509735 ext +20    ysm03@fayoum.edu.eg   
Sponsors and Collaborators
Fayoum University Hospital
Cairo University
Investigators
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Study Director: Kareem M Nawwar, MD Kasr ElAini Hospital, Faculty Of Medicine, Cairo Univerisity

Publications:
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Responsible Party: Doaa Lotfy, Assistant Lecturer of Anesthesiology, Fayoum University Hospital
ClinicalTrials.gov Identifier: NCT03646630     History of Changes
Other Study ID Numbers: D141
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Doaa Lotfy, Fayoum University Hospital:
lower abdominal surgeries
quadratus lumborum block
caudal block

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents