NCT03308136

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (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. 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

Conditions

• Lumbar Radiculopathy Due to Spinal Nerve Compression

Interventions

Type	Name	Description
PROCEDURE	1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.	1\) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
PROCEDURE	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.	2\) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3\~4ml of local anesthetics to the muscle layer along the expected needle pathway.
DRUG	1% Lidocaine	1% Lidocaine

Timeline

• Start date: 2017-10-16
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2017-10-12
• Last updated: 2019-01-11

Locations

1 site across 1 country: South Korea