Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
研究概览
简要总结
"Does low-does cervical epidural lidocaine cause transient weakness?"
详细描述
Cervical radicular pain is relatively common, often treated with epidural steroid injection (ESI), when conservative treatments like oral analgesics, physical therapy, and activity modification have failed. There are no universal clinical practice guidelines for the use of diluents when CESI are performed.
Interlaminar CESI may be performed with or without the use of local anesthetics, due to training bias or theoretical concerns of weakness. CESI without the benefit of local anesthetic as a steroid diluent increases the latency of pain relief and may decrease diagnostic information immediately after a CESI with regard to pain generators responsible for symptoms, and may potentially decrease patient satisfaction.
By evaluating the effects of local anesthetic as a diluent during interlaminar cervical ESI, we will enhance the safety of this treatment with regard to expectations of objective motor weakness as well as post procedure pain control in the recovery phase after the injection procedure.
Additionally, investigation of short-term pain, function, medication use, and global impression of change following use of local anesthetic versus saline as a diluent during interlaminar cervical ESI will provide evidence to inform the optimization of clinical outcomes related to steroid diluent choice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cervical radicular pain.
- •Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- •Numerical Rating Scale (NRS) pain score of 4 or higher.
- •Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
- •Patients who will undergo CESI for treatment of cervical radiculitis.
排除标准
- •Refusal to participate, provide consent, or provide communication and follow-up information for duration of the study.
- •Inability to perform handgrip or arm strength testing.
- •Contraindications to Cervical ESI (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for CIESI, and pregnancy).
- •Current glucocorticoid use or ESI within past 6 months.
- •Prior cervical spine surgery.
- •Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
- •Patient request for or requirement of conscious sedation for the injection procedure.
研究组 & 干预措施
cervical interlaminar with lidocaine
Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL).
干预措施: cervical interlaminar with lidocaine (Procedure)
cervical interlaminar with lidocaine
Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL).
干预措施: Lidocaine (Drug)
cervical interlaminar with lidocaine
Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL).
干预措施: Triamcinolone Acetonide (Drug)
cervical interlaminar with normal saline
Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL).
干预措施: cervical interlaminar with normal saline (Procedure)
cervical interlaminar with normal saline
Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL).
干预措施: Triamcinolone Acetonide (Drug)
cervical interlaminar with normal saline
Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL).
干预措施: Normal saline (Drug)
结局指标
主要结局
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
时间窗: 30 minutes post-procedure
Sensory Exam of upper extremity
Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
时间窗: 30 minutes post-procedure
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
次要结局
- Patient Global Impression of Change(one month follow up)
- Upper Extremity Functional Index(pre procedure, post-procedure, 1 day follow up, and one month follow up)
- Mean Arterial Blood Pressure Changes(30 minutes post-procedure)
- Heart Rate Changes(30 minutes post-procedure)
- Pain Medication(pre procedure, post-procedure, 1 day follow up, and one month follow up)
- Pain Intensity(pre procedure, post-procedure, 1 day follow up, and one month follow up)
研究者
Zack McCormick
Zachary L. McCormick, MD
University of Utah