NCT02833116Unknown4 期
Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial
Basque Health Service1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Pain.
研究概览
简要总结
This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.
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, Outcomes Assessor)
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
- •Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc.
- •Age between 18 and 80 years.
- •Moderate to severe pain (NVS>4).
- •Right proficient oral and written language.
排除标准
- •Patients with high intracranial pressure.
- •Patients with Multiple Sclerosis.
- •Patients with Guillain-Barré syndrome radiculopathy of vascular origin.
- •Patients with previous lumbar surgery.
- •Patients pregnant or lactating.
- •Patients with allergy or intolerance to any of the drugs used.
- •Patients with severe cognitive impairment.
- •Patients with intrathecal injectio radiculalgia.
- •Patients with poorly controlled major psychiatric pathology.
- •Patients with type I diabetes or poorly controlled type II diabetes (Hb1Ac>8.5).
- •Patients with glaucoma.
- •Patients with caudal equine syndrome.
- •Patients with pre-treatment with steroid injections/or local anesthetics.
- •Patients with central canal stenosis.
- •patients with chronic treatment with oral corticosteroids without stabilized pattern.
研究组 & 干预措施
Group Betamethasone
Experimental
One ampule containing 12 mg of betamethasone in a syringe of 10 ml
干预措施: Betamethasone (Drug)
Group Dexamethasone
Active Comparator
One ampule containing 4 mg of dexamethasone in a syringe os 10 ml
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Pain.
时间窗: 3 months.
Pain according to numerical visual pain scale.
次要结局
- Quality of life.(7 days, 1, 3 and 6 months.)
- Pain.(7 days, 1, 3 and 6 months.)
- Adverse events.(7 days, 1, 3 and 6 months.)
研究者
Enrique Manuel Barez Hernandez
Medical Doctor
Basque Health Service
研究点 (1)
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