NCT03825172

Brief Summary

Detailed study of ultrasonographic caudal epidural anatomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
348

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

January 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

January 11, 2022

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

January 24, 2019

Last Update Submit

December 22, 2021

Conditions

Keywords

Caudal blockUltrasoundChildrenRegional block anatomy

Outcome Measures

Primary Outcomes (3)

  • Definition Of Dural Sac Termination Level By Ultrasonography

    After general anesthesia, patient will be placed in lateral decubitus position. First, a 12 MHz lineer ultrasound transducer will be placed transversely to obtain the transverse view of sacral hiatus; in this view we will try to show two sacral cornua, sacrococcygeal ligament, posterior sacral bone and caudal epidural depth. Secondly, transducer will be turned parallel to the midline or paravertebral to obtain longitudinal view; in longitudinal view we will try to obtain the images of sacral vertebral corpuses, caudal epidural area and dural sac. We will try to determine the level of dural sac termination according to a part of vertabral corpus or an intervertebral distance.

    5 minutes

  • Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle

    Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle will be measured under longitudinal ultrasound view

    5 minutes

  • Definition Of Average Caudal Epidural Depth By Ultrasonography

    Definition of caudal epidural depth by ultrasonography will be obtained under transverse view for every patient and average value will be defined for every age group.

    5 minutes

Secondary Outcomes (1)

  • Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography

    5 minutes

Study Arms (3)

Group I

Caudal Epidural Ultrasonography will be performed in patients aged between 1-24 months

Diagnostic Test: Caudal Epidural Ultrasonography

Group II

Caudal Epidural Ultrasonography will be performed in patients aged between 25-48 months

Diagnostic Test: Caudal Epidural Ultrasonography

Group III

Caudal Epidural Ultrasonography will be performed in patients aged between 49-84 months

Diagnostic Test: Caudal Epidural Ultrasonography

Interventions

Ultrasonographic Measurement

Group IGroup IIGroup III

Eligibility Criteria

Age1 Month - 84 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric patients who are admitted to operating room for any pediatric surgery

You may qualify if:

  • Pediatric patients who applied for any pediatric surgery from 20 january to 20 july

You may not qualify if:

  • Premature patients
  • Patients who have any sendromic diagnosis
  • Patients who have any musculoskeletal abnormalities
  • Patients who have any spinal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Study Officials

  • Celal Kaya, MD

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 31, 2019

Study Start

January 28, 2019

Primary Completion

December 30, 2019

Study Completion

January 20, 2020

Last Updated

January 11, 2022

Record last verified: 2021-04

Locations