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Clinical Trials/NCT03789955
NCT03789955CompletedNot Applicable

Comparison of Contralateral Oblique View With the Lateral View for Mid-thoracic Epidural Assess: a Pilot Study

Asan Medical Center2 sites in 1 country30 target enrollmentStarted: February 22, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Distance between the tip of epidural needle and the baseline (CLO view - ventral interlaminar line, lateral view - spinolaminar line) at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)

Study Overview

Brief Summary

The aim of the present study is to compare contralateral oblique view with the lateral view for fluoroscopic guided mid-thoracic epidural assess.

Detailed Description

A thoracic epidural assess (block or catheter insertion) is a widely used intervention to reduce pain in patients with postherpetic neuralgia or who underwent chest and upper abdominal surgery.

In order to achieve the correct procedure, accurate access to the thoracic epidural space is needed. However, a thoracic epidural assess is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. The midthoracic region (T4-8) is the most difficult area when performing this procedure.

To overcome this issue, a method of approaching the thoracic epidural space through the contralateral oblique view (CLO view) has been introduced, however, unlike the cervical or lumbar spine, advantages of the CLO view over the lateral view or the optimal angle of the CLO view have not yet been studied. Therefore, we planned this study to investigate the advantages of the CLO view compared with the lateral view and to determine the optimal angles of the CLO view when fluoroscopic guided mid-thoracic epidural assess.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
20 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Scheduled for mid thoracic (T4-T8) epidural block or catheter insertion
  • •20 ≤ age <80
  • •Presence of thoracic MRI or CT
  • •When obtaining informed consent voluntarily

Exclusion Criteria

  • •Allergy to local anesthetics and contrast dye, and steroid
  • •Use of anticoagulants or antiplatelet medication, coagulopathy
  • •Infection at the insertion site
  • •Neurological or psychiatric disorders
  • •Prior spine instrumentation
  • •Pregnancy

Arms & Interventions

Fluoroscopic-guided TEB

Experimental

After assessment of the epidural space using the loss of resistance technique with air under fluoroscopic guidance, six fluoroscopic views will be obtained: true anteroposterior, contralateral oblique (CLO) at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral for comparison CLO view with lateral view.

Intervention: Fluoroscopic-guided TEB (Procedure)

Outcomes

Primary Outcomes

Distance between the tip of epidural needle and the baseline (CLO view - ventral interlaminar line, lateral view - spinolaminar line) at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)

Time Frame: One day after the procedure

Location of the needle tip was defined as being significantly before the baseline (-2), just before the baseline (-1), on the baseline (0), just after the baseline (+1), or significantly after the baseline (+2).

Secondary Outcomes

  • The quality of needle tip visualization at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)(One day after the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seong-Soo Choi, MD, PhD

Assistant Professor

Asan Medical Center

Study Sites (2)

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