Clinical Trials Directory

Trials / Completed

CompletedNCT03341182

The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. If a mirror is used during needle handling, overall procedure time and radiation exposure can be reduced.

Detailed description

1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient. 2. This study is single-blind because it is not possible to blind the practitioner performing the injection. 3. Subjects were randomly assigned to the normal method group (group A) and the mirror use group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers. 4. After the procedure, a resident who does not know of this study records the radiation exposure time displayed on the monitor and the overall procedure time

Conditions

Interventions

TypeNameDescription
PROCEDUREFluoroscopically Guided Lumbar Transforaminal Epidural InjectionsLay the subject down on the stomach and hold the pillow on the stomach. The skin of the injection area is sterilized by aseptic method and covered with aseptic pouch. After confirming the level of he vertebrae around the C-arm and aligning the anteroposterior view of the endplate of the vertebral body, rotate the C-arm 20\~30 degrees diagonally in the direction to be performed. After confirming the best Scotty dog view, confirm the final target point at 6 o'clock directly below the pedicle. At this position, the skin point is marked on the skin. And then both groups proceed in parallel with the beam direction of the transducer with the tunnel view technique until the needle reaches the back of the vertebral body at the level of the spinal nerve roots. At this time group A uses a mirror and group B dose not. The final reach of the target point (ideal depth) is confirmed through the anterior and posterior views and lateral views.
PROCEDUREconventional mannerA portable mirror is located at the side of surgical table and used in this procedure.

Timeline

Start date
2017-12-21
Primary completion
2018-08-21
Completion
2018-08-21
First posted
2017-11-14
Last updated
2019-01-22

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03341182. Inclusion in this directory is not an endorsement.