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

Lumbar Radiculopathy Due to Spinal Nerve Compression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308136
• Other study ID #: 4-2017-0683
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: February 28, 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 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:
• 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.
• 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

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	Procedural Pain score (NRS)	Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)	Immediately after the procedure
Secondary	At the next outpatient visit, whether the injection site pain(Yes) or not(No)	At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection.	2 weeks