Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
研究概览
简要总结
This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Synera® for 30min & Lidoderm® for 4 hours
Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
干预措施: Heated Lidocaine/Tetracaine Patch (Drug)
Synera® for 30min & Lidoderm® for 4 hours
Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
干预措施: 5% Lidocaine Patch (Drug)
Lidoderm® for 30min & Synera® for 4 hours
Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
干预措施: Heated Lidocaine/Tetracaine Patch (Drug)
Lidoderm® for 30min & Synera® for 4 hours
Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
干预措施: 5% Lidocaine Patch (Drug)
结局指标
主要结局
Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
时间窗: Approximately 5 months
次要结局
- Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.(Approximately 5 months)