Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Length of Action
研究概览
简要总结
Purpose and Background The purpose of this research study is to investigate the benefits of mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two commonly used medications to numb the skin for minor procedures. Lidocaine has a faster onset. Bupivacaine has a longer duration. They are often combined with epinephrine to increase the length of action. These medications are used to control pain at the time of the operation and to decrease discomfort immediately afterward. Participating in the study involves injection of local anesthetic containing lidocaine, bupivacaine, and lidocaine and bupivacain with epinephrine at 4 sites on the forearm. Your participation will potentially improve the administration of these medications in persons undergoing a variety of procedures. You will be one of approximately 25 healthy volunteer subjects in this research study.
详细描述
Procedures
During your participation the following procedures will be completed:
- You will be asked to read over and sign this consent form, if you choose to participate
- You will be asked demographic information and your medical history will be obtained
- If you are eligible to participate, the palm side of your forearm will be marked for the location of the treatments
- Four small injections will be made into the palm side of your forearms with the local anesthetic mixtures (you will not know which injection is used at each of the four injection sites)
- A small needle will be used for pinprick sensation to determine when numbness begins and ends
Length of Study and Number of Visits This study begins at the time the medications are injected and is completed when sensation has completely returned. The study will last between 6 and 12 hours. During this time, you may perform low intensity tasks including reading, typing, and writing. You must remain in the study location as the sites will frequently be examined.
Exclusions
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age: 18-60
排除标准
- •Pregnancy
- •allergy to local anesthetics
- •history of heart disease or diabetes
结局指标
主要结局
Length of Action
时间窗: Up to 12 hours
The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.
Onset of Action
时间窗: Up to 5 minutes
Time from infusion of local anesthetic to loss of sensation to sharp.
次要结局
未报告次要终点
研究者
James Collins
MD
Scott and White Hospital & Clinic