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

February 21, 2019 updated by: Yonsei University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection

Exclusion Criteria:

  • Local anesthetic allergy, coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: compression group
skin compression with an indicator for determination of needle entry point
Procedure: skin compression
skin compression with an indicator for determination of needle entry point
Active Comparator: non-compression group
non skin compression with an indicator for determination of needle entry point
Procedure: skin compression
skin compression with an indicator for determination of needle entry point

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total radiation exposure time
Time Frame: immediately ≤1 sec after the confirmation of successful epidural injection
Total radiation exposure time during whole epidural procedure.
immediately ≤1 sec after the confirmation of successful epidural injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of the needle readjustments
Time Frame: immediately ≤1 sec after the confirmation of successful epidural injection
The number of the needle readjustments for successful epidural injection
immediately ≤1 sec after the confirmation of successful epidural injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2014

Primary Completion (Actual)

October 10, 2015

Study Completion (Actual)

October 10, 2015

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

November 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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