Trans-foraminal Lumbar Epidural Injection of Dexmedetomidine Against Magnesium Sulfate When Combined With Dexamethasone in Uni-lateral Lower Limb Radicular Pain. Multi-centeric Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group. 25-75ys old
- •Both sex.
- •Lumber disc protrusion at one or two segments on MRI.
- •Chronic lumbar radiculer pain for more than 6 weeks refractory to
- •medical treatment for at least 4 weeks. .
- •Positve leg rising test at 30-70 degrees.
排除标准
- •Diabetic candidates ( type Ior II).
- •Patient refusal.
- •MRI with disc sequestration.
- •Neurological examination revealed foot drop, neuropathic ulcers
- •Myelopathic or scoliotic patients, .
- •Coagulopathic patients ( cirrhotic patients, on anti-coagulation )
研究组 & 干预措施
control group
Dexamethasone 4 mg (1ml) plus 40 mg ( 2ml) lidocaine 2% plus 1ml sterile saline
干预措施: transforaminal epidural injection of dexamethasone (Drug)
Magnesuim group
. 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml)
干预措施: epidural transforaminal injection of magnesuim sulfate (Drug)
Dexmedetomidine group
Dexmedetmodine 50mic (0.5ml) ,4 mg dexamethasone (1ml), 40 mg lidocaine 2% (2ml) added to 4ml total volume with sterile saline .
干预措施: epidural transforaminal injection of dexmedtemodine (Drug)
结局指标
主要结局
pain score
时间窗: up to 6 months post-injection
visual analogue pain score. pain value of (0 cm) equals no pain , and value of (10 cm) equals worst pain
次要结局
- functional disability(up to 6 months post injection)
- acute complications(6 hours post-injection)
研究者
Mina Maher
Lecturer of anesthesia and ICU
Minia University