Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Scores (NRS)
研究概览
简要总结
Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.
详细描述
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.
Hypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Hypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •undergoing unilateral or bilateral mastectomy
- •desiring analgesia with a paravertebral nerve block(s)
- •age 18 years or older
排除标准
- •morbid obesity as defined by a body mass index > 40
- •renal insufficiency
- •chronic opioid use
- •history of opioid abuse
- •any comorbidity which results in moderate or severe functional limitation
- •inability to communicate with the investigators or hospital staff
- •pregnancy
- •incarceration
结局指标
主要结局
Pain Scores (NRS)
时间窗: Day following Surgery
Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory
次要结局
- Opioid-related side effects(First 4 postoperative days)
- Cancer Recurrence(One Year following Surgery)
- Pain and Physical Functioning(Within first year of surgery)
- Pain scores(First 4 postoperative days)
- Opioid Requirements(First 4 postoperative days)
- Sleep Disturbances(First 4 postoperative days)
研究者
Brian M. Ilfeld, MD, MS
Associate Professor, In Residence
University of California, San Diego