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

Yonsei University

Status: Completed

Conditions: Lumbar Radiculopathy Due to Spinal Nerve Compression

Treatments: Procedure: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.; Drug: 1% Lidocaine; 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT03308136

4-2017-0683

Details and patient eligibility

About

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.

Full 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

Enrollment: 68 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

subcutaneous anesthesia group (group A)

Experimental group

Treatment:

Drug: 1% Lidocaine

Procedure: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.

muscle anesthesia group (group B)

Active Comparator group

Treatment:

Drug: 1% Lidocaine

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.