Lumbar Radiculopathy Due to Spinal Nerve Compression
Conditions
Keywords
epidural steroid injection, procedural pain, local Anesthetic Injection
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
Interventions
PROCEDURE1ml 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.
PROCEDURE1ml 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.
DRUG1% Lidocaine
1% Lidocaine
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
1. The subjects were randomly assigned to subcutaneous anesthesia group (group A) and muscle anesthesia group (group B), and the assigned results are unknown. 2. The Outcomes Assessor is not related to the study, and does not know its contents.
Intervention model description
subcutaneous anesthesia group (group A) muscle anesthesia group (group B)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain score (NRS) | Immediately after the procedure | Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| At the next outpatient visit, whether the injection site pain(Yes) or not(No) | 2 weeks | At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection. |
Countries
South Korea
Outcome results
None listed