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

Lumbar Radiculopathy Due to Spinal Nerve Compression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341182
• Other study ID #: 4-2017-0801
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: August 21, 2018

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.

Exclusion Criteria:

1. Blood clotting disorder

2. Infection around the site

3. Contrast agent allergy

4. Uncontrolled cardiovascular, cerebrovascular, kidney disease

5. Past history of spinal surgery (ex, spinal fusion)

6. If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)

7. Patients taking narcotic analgesics

Related Conditions & MeSH terms

• Lumbar Radiculopathy Due to Spinal Nerve Compression
• Radiculopathy

Intervention

Procedure:
• Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Lay 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.
• conventional manner
A portable mirror is located at the side of surgical table and used in this procedure.

Locations

Country	Name	City	State
Korea, Republic of	Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiation exposure time(second)	In both groups, overall procedure time recorded on the monitor is recorded after the procedure is over.	Immediately after the procedure