Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Spontaneous pain on numerical rating scale (NRS 0-10)
研究概览
简要总结
Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with peripheral nerve injury 3 months prior to participation
排除标准
- •Severe somatic or psychiatric diseases
- •Other peripheral neuropathy
- •Lack of ability to cooperate to the clinical examination
- •Allergy to Lidocaine or similar analgetics
研究组 & 干预措施
Lidocaine
Lidocaine 2 ml injection with 2% Adrenaline
干预措施: Lidocaine (Drug)
Isotonic Saline
Isotonic Saline 2 ml Injection
干预措施: Isotonic Saline (Drug)
结局指标
主要结局
Spontaneous pain on numerical rating scale (NRS 0-10)
时间窗: 15 minutes after injection
The participant will be asked about spontaneous pain
Evoked pain on numerical rating scale (NRS 0-10)
时间窗: 15 minutes after injection
次要结局
- Brush allodynia(15 minutes after injection)
- Cold allodynia(15 minutes after injection)
- Heat allodynia(15 minutes after injection)
- Pinprick hyperalgesia(15 minutes after injection)
