The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Procedural Pain score (NRS)
研究概览
简要总结
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.
详细描述
- A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
- This study is single-blind because it is not possible to blind the practitioner performing the injection.
- 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.
- 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.
- Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
- The subjects were randomly assigned to subcutaneous anesthesia group (group A) and muscle anesthesia group (group B), and the assigned results are unknown.
- The Outcomes Assessor is not related to the study, and does not know its contents.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
muscle anesthesia group (group B)
干预措施: 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. (Procedure)
muscle anesthesia group (group B)
干预措施: 1% Lidocaine (Drug)
subcutaneous anesthesia group (group A)
干预措施: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer. (Procedure)
subcutaneous anesthesia group (group A)
干预措施: 1% Lidocaine (Drug)
结局指标
主要结局
Procedural Pain score (NRS)
时间窗: Immediately after the procedure
Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)
次要结局
- At the next outpatient visit, whether the injection site pain(Yes) or not(No)(2 weeks)