The Superiority of Contralateral Obliqu… | Clinical Trial

Key information

Conditions

Herpes Zoster Cancer DNA Virus Infections Herpesviridae Infections Infections Neoplasms Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postherpetic Neuralgia Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan medical center, Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoroscopic-guided TEB

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.

Primary outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Dec 31, 2018
Registry last updated: Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed