Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients

Detailed study of ultrasonographic caudal epidural anatomy

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Pediatrics; Anatomy; Anesthesia, Caudal
• Intervention / Treatment: Diagnostic test: Caudal Epidural Ultrasonography

Detailed Description

Caudal epidural block is one of the most common methods to provide analgesia for an infraumbilical surgery in children. Although it can be carried out safely and easily, many complications have been described so far, because of inaccurate needle injections. To perform a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography is an important tool to perform pediatric regional blocks, including caudal blocks. We believe that caudal epidural ultrasound evaluation can be an important option to decrease complications and to achieve a successful attempt; due to that we will try to describe caudal epidural ultrasound imaging and changes from one month to 84 months.

• Study Type: Observational
• Enrollment (Actual): 348

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34098
    • Cerrahpasa Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Caudal Epidural Ultrasonography will be performed in patients aged between 1-24 months	Diagnostic test: Caudal Epidural Ultrasonography; Ultrasonographic Measurement
Group II; Caudal Epidural Ultrasonography will be performed in patients aged between 25-48 months	Diagnostic test: Caudal Epidural Ultrasonography; Ultrasonographic Measurement
Group III; Caudal Epidural Ultrasonography will be performed in patients aged between 49-84 months	Diagnostic test: Caudal Epidural Ultrasonography; Ultrasonographic Measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography	Sacral cornua will be palpated and than will be scanned under transverse ultrasound view. Also results will be compared.	5 minutes

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Ayse Cigdem Tutuncu; Kaya, Guner, M.D.; Pinar Kendigelen
• Investigators: Principal Investigator: Celal Kaya, MD, Istanbul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2019
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): January 20, 2020

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Children; Caudal block; Regional block anatomy
• Other Study ID Numbers: 72109855-604.01.01-103424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No