Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%
研究概览
简要总结
midazolam and dexamethasone both can counteract chronic pain. either via GABA mimetic action or via anti prostaglandins
详细描述
Entrapement syndrome - namely median nerve compression in carpal tunnel syndrome - causes chronic pain that can be refractory to medical treatment . Ultrasound guided hydrodissection is an option for alleviating pain . Recurrence is the main side effect of injection. We try in this research to prevent recurrence rate . Midazolam and dexamethasone both are used in chronic pain . Midazolm act by GABA mimetic action while dexamethasone act by decrease interleukin formation
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)
盲法说明
both drugs are the same colour and volume injected by a staff member not aware of study design
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines
- •Nerve cross sectional area >12mm2
排除标准
- •Refusal to participate
- •History of operation in median nerve.were patient refusal to participate, pain recurrence after previous injection and severe symptoms requiring surgical release, diabetic patients
研究组 & 干预措施
dexamethasone group
sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone
干预措施: Dexamethasone (Drug)
midazolam group
sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam
干预措施: Midazolam injection (Drug)
结局指标
主要结局
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%
时间窗: up to 6 months
use of visual analogue score
次要结局
- Subjective pain assesment(up to 6 months)
- complications(pain recurrence after 6 months, neurotoxicity immediately after injection)
- Nerve electrophysiology(up to 6 months)
- nerve sonogram(up to 6 months)
研究者
Mina Maher
Principle investigator
Minia University