Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT03825172
Collaborator
Pinar Kendigelen (Other), Ayse Cigdem Tutuncu (Other), Guner Kaya (Other)
348
1
11.7
29.7

Study Details

Study Description

Brief Summary

Detailed study of ultrasonographic caudal epidural anatomy

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
348 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
Actual Study Start Date :
Jan 28, 2019
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Jan 20, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Definition Of Dural Sac Termination Level By Ultrasonography [5 minutes]

    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.

  2. Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle [5 minutes]

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

  3. Definition Of Average Caudal Epidural Depth By Ultrasonography [5 minutes]

    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.

Secondary Outcome Measures

  1. Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography [5 minutes]

    Sacral cornua will be palpated and than will be scanned under transverse ultrasound view. Also results will be compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 84 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cerrahpasa Medical Faculty Istanbul Turkey 34098

Sponsors and Collaborators

  • Istanbul University
  • Pinar Kendigelen
  • Ayse Cigdem Tutuncu
  • Guner Kaya

Investigators

  • Principal Investigator: Celal Kaya, MD, Istanbul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celal Kaya, resident, Istanbul University
ClinicalTrials.gov Identifier:
NCT03825172
Other Study ID Numbers:
  • 72109855-604.01.01-103424
First Posted:
Jan 31, 2019
Last Update Posted:
Jan 11, 2022
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celal Kaya, resident, Istanbul University

Study Results

No Results Posted as of Jan 11, 2022