The Impact of Anesthetic Injection Rate, Temperature and Buffering on Pain Perception During Dermatologic Procedures: a Multicenter, Single-blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pain on a Visual Analog Scale (VAS)
研究概览
简要总结
This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception.
This study is a pilot study designed to determine feasibility of these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are undergoing dermatologic procedures.
- •Subjects ages 18-89 year old.
- •The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
排除标准
- •Subjects who are allergic to lidocaine.
- •History of bleeding tendency or coagulopathy.
- •Pregnant or lactating.
- •Active skin disease or skin infection in the treatment area.
- •Unable to understand the protocol or give informed consent.
- •Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
研究组 & 干预措施
Slow, Room Temperature
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Slow, Room Temperature Injection (Procedure)
Slow, Room Temperature
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Lidocaine (Drug)
Slow, Room Temperature
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Buffer (Drug)
Rapid, Room Temperature
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Rapid, Room Temperature Injection (Procedure)
Rapid, Room Temperature
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Lidocaine (Drug)
Rapid, Room Temperature
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Buffer (Drug)
Slow, Warmed
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Slow, Warm Temperature Injection (Procedure)
Slow, Warmed
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Lidocaine (Drug)
Slow, Warmed
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Buffer (Drug)
Rapid, Warmed
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Rapid, Warm Temperature Injection (Procedure)
Rapid, Warmed
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Lidocaine (Drug)
Rapid, Warmed
In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
干预措施: Buffer (Drug)
Buffered
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
干预措施: Buffered Injection (Procedure)
Buffered
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
干预措施: Lidocaine (Drug)
Buffered
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
干预措施: Buffer (Drug)
Non-Buffered
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
干预措施: Non-Buffered Injection (Procedure)
Non-Buffered
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain on a Visual Analog Scale (VAS)
时间窗: intraoperative
Subjects will rate the pain VAS score immediately after the needle is withdrawn. They will be asked to rate the pain of the injection of the solution. VAS pain scale is rated on a 10 cm scale with 0 cm being no pain and 10 cm being extremely painful.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University