Comparison of Two Lidocaine Administration Techniques
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 481
- 试验地点
- 1
- 主要终点
- Pain Assessment: Overall
研究概览
简要总结
The objective of our study is to determine if technique of lidocaine administration can decrease pain perception.
Hypothesis: There will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.
详细描述
This is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. Subjects will be approached and consented to participate in the study. They will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. An investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine.
排除标准
- •Patient who lack decisional capacity to consent
- •Patients who lack the ability to answer questions in english using pain scales
研究组 & 干预措施
lidocaine onto skin prior to lidocaine subcutaneous injection
1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine.
干预措施: lidocaine (Drug)
lidocaine subcutaneous injection alone
1% lidocaine subcutaneous injection alone by standard approach
干预措施: lidocaine (Drug)
结局指标
主要结局
Pain Assessment: Overall
时间窗: post procedure (day 1)
Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome.
次要结局
- Pain Assessment: Lidocaine Injection(post procedure (day 1))
- Pain Assessment: During Procedure(post procedure (day 1))