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Clinical Trials/NCT03780790
NCT03780790
Completed
N/A

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

Istanbul University1 site in 1 country135 target enrollmentDecember 28, 2018
InterventionsBupivacaine

Overview

Phase
N/A
Intervention
Bupivacaine
Conditions
Anesthesia, Local
Sponsor
Istanbul University
Enrollment
135
Locations
1
Primary Endpoint
Face, Legs Activity, Cry, Consolability (FLACC) scores
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 28, 2018
End Date
February 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meltem Savran Karadeniz

Associated Professor

Istanbul University

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Bupivacaine

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

Intervention: Bupivacaine

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

Intervention: Bupivacaine

Outcomes

Primary Outcomes

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

  • First analgesic requirement time(Up to 48 hours)
  • Hospital stay(Through study completion, an average of 1 week)
  • Number of patients who require rescue analgesic(up to 48 hours)

Study Sites (1)

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