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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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ClinicalTrials.gov Identifier: NCT02281227
Recruitment Status : Unknown
Verified October 2014 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : November 3, 2014
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Low Back Pain Due to Spinal Nerve Compression Procedure: skin compression

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : October 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Total radiation exposure time [ Time Frame: immediately ≤1 sec after the confirmation of successful epidural injection ]
    Total radiation exposure time during whole epidural procedure.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Local anesthetic allergy, coagulopathy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281227


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Shin Hyung Kim, MD    82-2-2227-3556    tessar@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02281227     History of Changes
Other Study ID Numbers: 4-2014-0721
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms