跳至主要内容
临床试验/NCT02930551
NCT02930551已完成不适用

Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study

Danish Pain Research Center1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Lidocaine 2 ml injection with 2% Adrenaline

干预措施: Lidocaine (Drug)

Isotonic Saline

Placebo Comparator

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)

研究者

发起方
Danish Pain Research Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验