Clinical trial NCT03789955: The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess
Official title: Comparison of Contralateral Oblique View With the Lateral View for Mid-thoracic Epidural Assess: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Zoster
Postherpetic Neuralgia
Cancer
Keywords: Fluoroscopy
Contralateral Oblique View
Thoracic epidural block
Mid thoracic epidural space
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: One day after the procedure
Secondary outcomes:
measure: The quality of needle tip visualization at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)
timeFrame: One day after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
city: Seoul
country: Korea, Republic of
facility: Seong-Soo Choi
Study officials:
affiliation: Asan Medical Center
name: Seong-Soo Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.