Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. It is possible that this pain is caused because lidocaine is acidic. Some physicians believe that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care by radiologists today. The purpose of this study is to determine if either approach is more comfortable for patients having breast procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 Years of age
- •Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging
排除标准
- •Less than 21 Years of age
- •Allergic to Lidocaine or Sodium Bicarbonate
- •Not mentally capable of consenting
研究组 & 干预措施
1% Lidocaine
1% Lidocaine alone.
干预措施: 1% Lidocaine (Drug)
1% Lidocaine plus sodium bicarbonate
1% Lidocaine plus 8.4% sodium bicarbonate
干预措施: 1% Lidocaine plus sodium bicarbonate (Drug)
结局指标
主要结局
Pain
时间窗: immediately prior to anesthetizing, within approximately 1 minute of starting
Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.
次要结局
- Pain(immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting)