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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 : Completed
First Posted : November 2, 2014
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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 Phase
Low Back Pain Due to Spinal Nerve Compression Procedure: skin compression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Actual Study Start Date : October 20, 2014
Actual Primary Completion Date : October 10, 2015
Actual Study Completion Date : October 10, 2015

Resource links provided by the National Library of Medicine


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




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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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

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
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02281227    
Other Study ID Numbers: 4-2014-0721
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms