Back to resultsDetermination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
Primary Purpose
Low Back Pain Due to Spinal Nerve Compression
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
skin compression
Sponsored by
About this trial
This is an interventional other trial for Low Back Pain Due to Spinal Nerve Compression
Eligibility Criteria
Inclusion Criteria:
- Adult patients with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection
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
compression group
non-compression group
Arm Description
skin compression with an indicator for determination of needle entry point
non skin compression with an indicator for determination of needle entry point
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
1. Study Identification
Unique Protocol Identification Number
NCT02281227
Brief Title
Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2014 (Actual)
Primary Completion Date
October 10, 2015 (Actual)
Study Completion Date
October 10, 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
To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain Due to Spinal Nerve Compression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
compression group
Arm Type
Active Comparator
Arm Description
skin compression with an indicator for determination of needle entry point
Arm Title
non-compression group
Arm Type
Active Comparator
Arm Description
non skin compression with an indicator for determination of needle entry point
Intervention Type
Procedure
Intervention Name(s)
skin compression
Intervention Description
skin compression with an indicator for determination of needle entry point
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 with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection
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
Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
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