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

NCT ID: NCT03789955

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2019-11-07

Brief Summary

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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

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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.

Conditions

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Herpes Zoster Postherpetic Neuralgia Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fluoroscopic-guided TEB

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seong-Soo Choi, MD, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seong-Soo Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan medical center

Seoul, , South Korea

Site Status

Seong-Soo Choi

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33400438 (View on PubMed)

Other Identifiers

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2018-1551

Identifier Type: -

Identifier Source: org_study_id

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