Quantifying the Phoenix Sign: A Comparative, Randomized Control Trial Analysis of Lidocaine and Papaverine-Induced Vascular Enhancement After Common Peroneal (Fibular) Nerve Blocks for the Diagnosis of a Focal Peripheral Nerve Entrapment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Manual Motor Strength Testing of Anterior Compartment
研究概览
简要总结
This pilot study aims to investigate the effects of nerve blocks in patients with diabetic peripheral neuropathy through a double-blinded, randomized trial involving 4 patients. Each participant will receive bilateral peripheral nerve blocks using either lidocaine or papaverine. Following randomization, each patient will receive one medication in one leg and the alternate medication in the contralateral leg. Researchers will measure parameters including motor strength, sensory function (two-point discrimination), arterial blood flow via Doppler ultrasound, and microvascular perfusion using near-infrared spectroscopy both prior to and following nerve block administration. This research seeks to explore potential diagnostic and therapeutic applications for peripheral nerve entrapment, a common yet challenging clinical condition.
详细描述
Detailed Analysis of the Phoenix Sign and Vascular Changes Following Nerve Blocks in Diabetic Neuropathy
Study Background and Purpose
This study investigates the vascular and neurological phenomena associated with peripheral nerve blocks in patients with diabetic neuropathy. The primary aim is to assess whether observed changes following nerve block administration can be attributed to vasodilatory effects of lidocaine or neurological mechanisms.
Common peroneal nerve (CPN) entrapment is the third most common nerve entrapment pathology in humans and frequently results in foot drop, characterized by difficulty lifting the front part of the foot.
Study Design and Methodology
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects were included if they were diabetic and neuropathic.
排除标准
- •Patients with Trypanophobia
研究组 & 干预措施
Lidocaine group
This arm is randomized to the laterality of the subject for either lidocaine or papaverine
干预措施: Lidocaine infiltration (Drug)
Papavarine
This arm is randomized to the laterality of the subject for either lidocaine or papaverine, for the first infiltration. The contralateral extremity will then receive the agent that was not administered on the first side from randomization.
干预措施: Infiltration of papaverine (Drug)
结局指标
主要结局
Manual Motor Strength Testing of Anterior Compartment
时间窗: From enrollment to 1 day of testing
Movement Against Manual Resistance (MAMR) was evaluated using a scale of 1-5 out of 5. This was normalized so that 1/5 = 0.2, and 5/5=1.0. This was performed on three muscles of the anterior compartment, extensor hallusis longus (EHL), tibialis anterior (TA), and extensor digitorum longus (EDL) and the result for three muscles were averaged. In addition, the EHL was evaluated with a dynamometer, in Newtons (N) separately.
次要结局
未报告次要终点
研究者
Stephen Barrett
US Neuropathy Centers Medical Director
US Neuropathy Centers