The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections

Yonsei University1 site in 1 country68 target enrollmentOctober 16, 2017

ConditionsLumbar Radiculopathy Due to Spinal Nerve Compression

Interventions1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.1% Lidocaine 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.

Drugs1% Lidocaine

Overview

Phase: Not Applicable
Intervention: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.
Conditions: Lumbar Radiculopathy Due to Spinal Nerve Compression
Sponsor: Yonsei University
Enrollment: 68
Locations: 1
Primary Endpoint: Procedural Pain score (NRS)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. But needle handling during the procedure may cause pain and discomfort to the patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In addition, it can reduce the injection site pain that may occur after the procedure.

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 subcutaneous anesthesia group (group A) and the muscle anesthesia 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 patient's pain and discomfort. and on follow-up visits, post injection site pain is checked. 5. Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner

Registry

clinicaltrials.gov

Start Date

October 16, 2017

End Date

February 28, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

•Blood clotting disorder
•Infection around the site
•Contrast agent allergy
•Uncontrolled cardiovascular, cerebrovascular, kidney disease
•Past history of spinal surgery (ex, spinal fusion)
•If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
•Patients taking narcotic analgesics

Arms & Interventions

muscle anesthesia group (group B)

Intervention: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.