A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine if the 5% lidocaine patch can decrease the pain from epidural placement.
研究概览
简要总结
Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Laboring patients between the ages of 18 and 45 with a BMI of less than 45
排除标准
- 未提供
研究组 & 干预措施
5% lidocaine patch
If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
干预措施: 5% lidocaine patch (Drug)
placebo patch
If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
干预措施: placebo patch (Drug)
结局指标
主要结局
To determine if the 5% lidocaine patch can decrease the pain from epidural placement.
时间窗: a minimum of 30 minutes from patch placement and a maximum of 12 hours
次要结局
未报告次要终点
研究者
Richard Applegate
MD
Loma Linda University