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The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess

Primary Purpose

Herpes Zoster, Postherpetic Neuralgia, Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluoroscopic-guided TEB
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Herpes Zoster focused on measuring Fluoroscopy, Contralateral Oblique View, Thoracic epidural block, Mid thoracic epidural space

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan medical center
  • Seong-Soo Choi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluoroscopic-guided TEB

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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 Outcome Measures

The quality of needle tip visualization at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)
The clarity of the needle tip was subjectively graded as 1 (clearly visualized without ambiguity), 2 (poorly visualized or visualized with effort), or 3 (not visualized).

Full Information

First Posted
December 27, 2018
Last Updated
November 18, 2019
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03789955
Brief Title
The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess
Official Title
Comparison of Contralateral Oblique View With the Lateral View for Mid-thoracic Epidural Assess: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Postherpetic Neuralgia, Cancer
Keywords
Fluoroscopy, Contralateral Oblique View, Thoracic epidural block, Mid thoracic epidural space

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoroscopic-guided TEB
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Fluoroscopic-guided TEB
Intervention Description
When performing a fluoroscopic-guided thoracic epidural block (TEB), an 18-gauge Tuohy needle will be used for interlaminar epidural access. If the epidural space was accessed under fluoroscopic guidance and using the loss of resistance technique with air. All procedures will be performed with a paramedian approach under the true AP and lateral view at first, If the interlaminar space is not visible, the CLO view will be used. If the needle is deemed to be in the epidural space when the loss occurred, six fluoroscopic views will be obtained: true AP, CLO at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral. The CLO measured angle will be determined by measuring the angle between the superior lamina and spinous process on the midsagittal plane on thoracic MRI or CT.
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
One day after the procedure
Secondary Outcome Measure Information:
Title
The quality of needle tip visualization at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)
Description
The clarity of the needle tip was subjectively graded as 1 (clearly visualized without ambiguity), 2 (poorly visualized or visualized with effort), or 3 (not visualized).
Time Frame
One day after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Soo Choi, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seong-Soo Choi
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33400438
Citation
Kim DH, Yoon SH, Lee J, Park H, Sim JH, Choi SS. Evaluation of Contralateral Oblique and Lateral Views for Mid-Thoracic Epidural Access: A Prospective Observational Study. Pain Physician. 2021 Jan;24(1):E51-E59.
Results Reference
derived

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The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess

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