NCT03780790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

December 28, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

November 20, 2018

Last Update Submit

March 28, 2022

Conditions

Anesthesia, Local

Keywords

quadratus lumborum blocktransversus abdominis plane blockcaudal blockultrasound-guided

Outcome Measures

Primary Outcomes (1)

  • Face, Legs Activity, Cry, Consolability (FLACC) scores

    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.

    up to 48 hours

Secondary Outcomes (3)

  • Hospital stay

    Through study completion, an average of 1 week

  • Number of patients who require rescue analgesic

    up to 48 hours

  • First analgesic requirement time

    Up to 48 hours

Other Outcomes (3)

  • Incidence of side effects

    up to 48 hours

  • Incidence of complications

    up to first week

  • Time to first mobilization

    up to 48 hours

Study Arms (3)

Quadratus Lumborum Block

ACTIVE COMPARATOR

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

Transversus Abdominis Plane Block

ACTIVE COMPARATOR

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

Caudal Block

ACTIVE COMPARATOR

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

Interventions

BupivacaineDRUG

% 0,25

Also known as: Marcaine
Caudal BlockQuadratus Lumborum BlockTransversus Abdominis Plane Block

Eligibility Criteria

Age12 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • undergoing lower abdominal surgery
  • ASA(American Society of Anestesiology)1-2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Meltem Savran Karadeniz

    Istanbul University Faculty of Medicine Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

November 20, 2018

First Posted

December 19, 2018

Study Start

December 28, 2018

Primary Completion

February 1, 2021

Study Completion

February 25, 2021

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

TU(1)