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

November 18, 2019 updated by: Seong-Soo Choi, MD, PhD, Asan Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 05505
        • Seong-Soo Choi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoroscopic-guided TEB
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.
Procedure: Fluoroscopic-guided TEB
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One day after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of needle tip visualization 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
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).
One day after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Seong-Soo Choi, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2019

Primary Completion (Actual)

November 7, 2019

Study Completion (Actual)

November 7, 2019

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-1551

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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