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Comparing Analgesic Effects of Three Ultrasound Guided Regional Anesthetic Techniques in Pediatrics

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT03780790
Collaborator
(none)
135
Enrollment
1
Location
3
Arms
26
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates analgesic effects of ultrasound-guided (USG) regional anesthetic techniques; caudal block , transversus abdominis plane (TAP) block and quadratus lumborum block (QLB) by comparing postoperative pain scores [ Face, Legs, Activity, Cry, Consolabilty(FLACC) and Visual Analogue Scale (VAS)], first analgesic requirement time and total analgesic consumption in pediatrics undergoing lower abdominal surgery. We also aim to observe the side effects of these techniques such as nausea, vomiting, bradycardia, hypotension, respiratory depression.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides effective postoperative analgesia. Neuroaxial blocks such as epidural and caudal blocks is considered the gold standart regional technique for pain management after lower abdominal surgery, blocking both somatic and visceral pain. Nowadays,US is increasingly used to perform caudal block, demostrating cannule placement and precise deposition of local anesthetic in the epidural space. On the other side truncal blocks as US-guided TAP block covers T10-L1 dermatomes and provides postoperative pain relief after lower abdominal surgery with lower complication rate rather than caudal block but it may not prevent traction on the peritoneal sac. QLB is rather a new regional technique blocking nerve roots close to paravertebral area affecting somatic and visceral nerve fibers. In our study we aim to compare postoperative analgesic effects of these three techniques in paediatrics. Our primary outcomes are pain scores(FLACC/VAS) and first additional analgesic requirement time. Secondary outcomes are total analgesic consumption, side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), length of hospitalization and chronic pain due to incision after 2 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RANDOMISED DOUBLE BLINDED INTERVENTIONALRANDOMISED DOUBLE BLINDED INTERVENTIONAL
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
A Prospective Randomized Trial Comparing Analgesic Effects of Three Ultrasound-guided Regionel Anesthetic Techniques in Pediatrics: Caudal Analgesia, Transversus Abdominis Plane and Quadratus Lumborum Blocks
Actual Study Start Date :
Dec 28, 2018
Actual Primary Completion Date :
Feb 1, 2021
Actual Study Completion Date :
Feb 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Quadratus Lumborum Block

US-guided quadratus lumborum block will be performed with 0,5 ml/kg 0.25% Bupivacaine in the anterior layer of the thoracolumbar fascia between psoas major and quadratus lumborum muscles

Drug: Bupivacaine
% 0,25
Other Names:
  • Marcaine

    		•
    Active Comparator: Transversus Abdominis Plane Block

    US- guided transversus abdominis plane block will be performed with 0,5 ml/kg 0.25% Bupivacaine into the fascial plane between internal oblique muscle and transversus abdominis muscle

    Drug: Bupivacaine
    % 0,25
    Other Names:
  • Marcaine

    		•
    Active Comparator: Caudal Block

    US-guided caudal epidural block will be applied to 0.7 ml/kg 0.25 % Bupivacaine up to a maximum of 20 mL

    Drug: Bupivacaine
    % 0,25
    Other Names:
  • Marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Face, Legs Activity, Cry, Consolability (FLACC) scores [up to 48 hours]

      It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.

    Secondary Outcome Measures

    1. Hospital stay [Through study completion, an average of 1 week]

      Hospitalisation

    2. Number of patients who require rescue analgesic [up to 48 hours]

      Number of patients who require IV tramadol (1 mg/kg) at the first 2 hours and parasetamol in the 48 hours

    3. First analgesic requirement time [Up to 48 hours]

      Duration of postoperative analgesia

    Other Outcome Measures

    1. Incidence of side effects [up to 48 hours]

      Nausea, vomiting

    2. Incidence of complications [up to first week]

      Hematoma, dural puncture, infections

    3. Time to first mobilization [up to 48 hours]

      Time to first mobilization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • undergoing lower abdominal surgery

    • ASA(American Society of Anestesiology)1-2

    Exclusion Criteria:

    • denial of patient or parents,

    • infection on the local anesthetic application area

    • infection in central nervous system

    • coagulopathy

    • brain tumours

    • known allergy against local anesthetics

    • anatomical difficulties

    • with preexisting cardiac dysfunction

    • with history of renal and/or hepatic dysfunction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Istanbul Turkey 34

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Principal Investigator: Meltem Savran Karadeniz, Istanbul University Faculty of Medicine Department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Meltem Savran Karadeniz, Associated Professor, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT03780790
    Other Study ID Numbers:
    • 2018/1076
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meltem Savran Karadeniz, Associated Professor, Istanbul University
    quadratus lumborum block
    transversus abdominis plane block
    caudal block
    ultrasound-guided
    Additional relevant MeSH terms:
    Bupivacaine

    Study Results

    No Results Posted as of Apr 6, 2022