Comparison of Long Acting vs. Short Acting Anesthetic Agents as a Tool for Improving Pain Management Post Ultrasound Guided Breast Biopsy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in pain level from baseline to 1 hour
研究概览
简要总结
This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast.
详细描述
The purpose of this study is to evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast. One group of patients will receive lidocaine alone for local anesthesia. A second group of patients will similarly receive lidocaine prior to tissue sampling, followed by infiltration of the biopsy area with ropivacaine.
Our hypothesis is that patients who receive a long acting anesthetic (ropivacaine) along with the popular short acting anesthetic (lidocaine), will be pain free after the breast biopsy procedure for a longer period of time than the patients who only receive lidocaine (the short acting anesthetic). This will lessen the emotional and physical trauma associated with the procedure and give patients a better experience thereby improving patient care.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with breast lesions recommended for biopsy by physician
排除标准
- •Patients with breast lesions not recommended for biopsy
- •Patients with allergic reactions to lidocaine, ropivacaine, or related anesthetics
研究组 & 干预措施
Lidocaine alone
Lidocaine: 8-10 ml of Lidocaine by subcutaneous injection
干预措施: Lidocaine alone (Drug)
Lidocaine Ropivacaine
Lidocaine Ropivacaine
- 8-10 ml of Lidocaine given by subcutaneous injection
- 8-10 ml of Ropivacaine given by subcutaneous injection
干预措施: Lidocaine Ropivacaine (Drug)
结局指标
主要结局
Change in pain level from baseline to 1 hour
时间窗: 1 hour after procedure
Amount of pain that patient is feeling at baseline and 1 hour after the procedure
次要结局
- Change in pain level from 5 to 10 hours after the procedure(10 hours after procedure)
- Change in pain level from 10 to 24 hours after procedure(24 hours after procedure)
- Pathology(up to 72 hours after procedure)
- Change in pain level from 1 hour to 5 hours after procedure(5 hours)