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

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03789955
Collaborator
(none)
30
2
1
8.5
15
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fluoroscopic-guided TEB
N/A

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
Actual Enrollment :
30 participants
Allocation:
N/A
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 :
Feb 22, 2019
Actual Primary Completion Date :
Nov 7, 2019
Actual Study Completion Date :
Nov 7, 2019

Arms and Interventions

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.

Outcome Measures

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) [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) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 79 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan medical center Seoul Korea, Republic of 05505
2 Seong-Soo Choi Seoul Korea, Republic of 05505

Sponsors and Collaborators

  • Asan Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seong-Soo Choi, MD, PhD, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT03789955
Other Study ID Numbers:
  • 2018-1551
First Posted:
Dec 31, 2018
Last Update Posted:
Nov 19, 2019
Last Verified:
Nov 1, 2019
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, Assistant Professor, Asan Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2019