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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02281227
First received: October 23, 2014
Last updated: October 29, 2014
Last verified: October 2014
  Purpose
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 Intervention
Low Back Pain Due to Spinal Nerve Compression Procedure: skin compression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 64
Study Start Date: October 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 23, 2014
Last Updated: October 29, 2014

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

ClinicalTrials.gov processed this record on September 21, 2017