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

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ClinicalTrials.gov Identifier: NCT03789955
Recruitment Status : Completed
First Posted : December 31, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Seong-Soo Choi, MD, PhD, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Postherpetic Neuralgia Cancer Procedure: Fluoroscopic-guided TEB Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Contralateral Oblique View With the Lateral View for Mid-thoracic Epidural Assess: a Pilot Study
Actual Study Start Date : February 22, 2019
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).



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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789955


Locations
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Korea, Republic of
Asan medical center
Seoul, Korea, Republic of, 05505
Seong-Soo Choi
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Seong-Soo Choi, MD, PhD Asan Medical Center

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Responsible Party: Seong-Soo Choi, MD, PhD, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03789955     History of Changes
Other Study ID Numbers: 2018-1551
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seong-Soo Choi, MD, PhD, Asan Medical Center:
Fluoroscopy
Contralateral Oblique View
Thoracic epidural block
Mid thoracic epidural space
Additional relevant MeSH terms:
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Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases