- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789955
The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess
Comparison of Contralateral Oblique View With the Lateral View for Mid-thoracic Epidural Assess: a Pilot Study
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 05505
- Seong-Soo Choi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
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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
Sponsor
Investigators
- Principal Investigator: Seong-Soo Choi, MD, PhD, Asan Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1551
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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