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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03825172
Other study ID # 72109855-604.01.01-103424
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 28, 2019
Est. completion date January 20, 2020

Study information

Verified date April 2021
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Detailed study of ultrasonographic caudal epidural anatomy


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.


Recruitment information / eligibility

Status Completed
Enrollment 348
Est. completion date January 20, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Month to 84 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Caudal Epidural Ultrasonography
Ultrasonographic Measurement

Locations

Country Name City State
Turkey Cerrahpasa Medical Faculty Istanbul

Sponsors (4)

Lead Sponsor Collaborator
Istanbul University Ayse Cigdem Tutuncu, Guner Kaya, Pinar Kendigelen

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
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