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Completed

NCT Number: NCT03780790

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

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.

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Key information

Conditions

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, 34, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

% 0,25

Other names: Marcaine

Primary outcomes

  1. Face, Legs Activity, Cry, Consolability (FLACC) scores

    Time frame: 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 outcomes

  1. Hospital stay

    Time frame: Through study completion, an average of 1 week

    Hospitalisation

  2. Number of patients who require rescue analgesic

    Time frame: 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

    Time frame: Up to 48 hours

    Duration of postoperative analgesia

Other outcomes

  1. Incidence of side effects

    Time frame: up to 48 hours

    Nausea, vomiting

  2. Incidence of complications

    Time frame: up to first week

    Hematoma, dural puncture, infections

  3. Time to first mobilization

    Time frame: up to 48 hours

    Time to first mobilization

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2018
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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