Prospectively Assessing Pain After Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Number of narcotic pain pills used after surgery
研究概览
简要总结
Reducing post-operative pain and reducing the use of opioid narcotics are independently valuable goals. Before studying newer techniques that may help us achieve these goals, we need objective data on how much pain normally occurs after breast surgery done with standard-of-care techniques. This study was designed to obtain baseline data.
详细描述
Breast surgeons may be able to reduce post-operative pain and the need for opioid narcotics by utilizing regional anesthesia techniques (modified regional blocks) during surgery. To test this hypothesis, we need baseline (pre-intervention) data on how much pain patients experience when breast surgery is done without blocks.
In this study, we will gather data on (1.) pain pills used after surgery, and (2.) pain scores in the recovery room. This will allow us to establish how much pain normally occurs after axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy, done by a participating breast surgeon.
After analyzing this data, our plan is to do a second study, with a new group of patients, to assess whether there is any change in outcome after surgeons implement these new techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Female, age 18 or older.
- •Scheduled for axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy.
- •Able to take oral narcotics and be willing to adhere to the prescribed regimen.
排除标准
- •A history of chronic pain
- •Any previously diagnosed chronic pain syndrome.
- •Prior use of narcotics, on more than 5 days in the past 3 months or 10 days in the past year.
结局指标
主要结局
Number of narcotic pain pills used after surgery
时间窗: Assessed approximately a week after surgery
Pain scores in recovery room
时间窗: The day of surgery
EMR documentation from the recovery room
次要结局
未报告次要终点
研究者
Scott Karlan
M.D.
Cedars-Sinai Medical Center