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Fluoroscopically-guided Epidural Block in the Midthoracic Region: A Comparison of Anterioposterior Versus Oblique View Approach

Primary Purpose

Low Back Pain Requiring Epidural Injection

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oblique view approach
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain Requiring Epidural Injection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients who were scheduled for the transforaminal epidural injection in midthoracic region (T5-T7)

Exclusion Criteria:

  • Local anesthetic allergy, coagulopathy

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AP group

OB group

Arm Description

oblique view approach during transforaminal epidural block

oblique view approach during transforaminal epidural block

Outcomes

Primary Outcome Measures

Total radiation exposure time
Total radiation exposure time during whole epidural procedure.

Secondary Outcome Measures

The number of the needle readjustments
The number of the needle readjustments for successful epidural injection

Full Information

First Posted
November 20, 2014
Last Updated
March 20, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02300714
Brief Title
Fluoroscopically-guided Epidural Block in the Midthoracic Region: A Comparison of Anterioposterior Versus Oblique View Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of assistance and time to carry out the research.
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 14, 2015 (Actual)
Study Completion Date
July 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A comparison of anterioposterior versus oblique view approach method for fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate differences on total radiation time and technical feasibility between anterioposterior and oblique view approach method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain Requiring Epidural Injection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AP group
Arm Type
Active Comparator
Arm Description
oblique view approach during transforaminal epidural block
Arm Title
OB group
Arm Type
Active Comparator
Arm Description
oblique view approach during transforaminal epidural block
Intervention Type
Procedure
Intervention Name(s)
oblique view approach
Primary Outcome Measure Information:
Title
Total radiation exposure time
Description
Total radiation exposure time during whole epidural procedure.
Time Frame
immediately ≤1 sec after the confirmation of successful epidural injection
Secondary Outcome Measure Information:
Title
The number of the needle readjustments
Description
The number of the needle readjustments for successful epidural injection
Time Frame
immediately ≤1 sec after the confirmation of successful epidural injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients who were scheduled for the transforaminal epidural injection in midthoracic region (T5-T7) Exclusion Criteria: Local anesthetic allergy, coagulopathy
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Fluoroscopically-guided Epidural Block in the Midthoracic Region: A Comparison of Anterioposterior Versus Oblique View Approach

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