Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Indication of pain relieved extremity
研究概览
简要总结
The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy
详细描述
Both peripheral and central changes in the nervous system contribute to the development of painful diabetic neuropathy, but how these changes contribute to the pain generation remains yet to be fully understood.
The purpose of this study is to evaluate if a peripheral regional nerve block relieves spontaneous pain in painful diabetic polyneuropathy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Probably diabetic neuropathy confirmed using the Toronto criteria in a "conservative manner", i.e. three out of three symptoms/signs of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes)
- •Definite or probable neuropathic pain for minimum the last 6 months
- •Mean pain intensity at > 4 NRS the last week
- •Since we expect a large effect of the block it is not necessary to discontinue pain medication.
排除标准
- •Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain.
- •Unable to understand and speak Danish.
- •Non-cooperative.
- •Warfarin or other medication that contraindicate regional anesthesia.
- •Infection in the injection area.
- •Allergy to lidocaine.
- •Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception).
- •Severe psychiatric disease e.g. severe depression during the last 6 months.
- •Alcohol or drug abuse.
结局指标
主要结局
Indication of pain relieved extremity
时间窗: 30 minutes
Number of participants who indicated the leg with lidocaine as most pain relieved 30 minutes after block And number of participants who indicated the leg with saline as most pain relieved 30 minutes after block
次要结局
- Pain relief(45 minutes)
- Pain intensity(90 minutes)
- Pain symptomps(50 minutes)
- Hyperalgesia and allodynia(90 minutes)
- Distribution of evoked pain(60 minutes)