Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
- 试验地点
- 14
- 主要终点
- number of patients that have moderate to severe pain
研究概览
简要总结
The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
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
- Double (Participant, Investigator)
盲法说明
Treatment assignments can be viewed only by the hospital pharmacists who are dispensing the study drugs.
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
- •Patients ≥ 18 years of age
- •Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection
- •Patients scheduled for surgery at the JRSC or MSK Monmouth
- •Previously enrolled patients > 6 months from contralateral mastectomy
排除标准
- •Patients who are non-English speaking
- •Patients having any immediate breast reconstructive procedure
- •Patients are having bilateral mastectomy
- •Patients who report a baseline pain score > 3, unrelated to a breast procedure
- •Patients who take long acting opioid medication use
- •Patients will be excluded if they are having their mastectomy performed with tumescence
- •Patients weighing < 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose
- •Patients within 6 months of previous enrollment for surgery for contralateral mastectomy
研究组 & 干预措施
Bupivacaine + usual post-operative medications
The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
干预措施: patient-reported pain scores (Behavioral)
Bupivacaine + usual post-operative medications
The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
干预措施: Bupivacaine (Drug)
Saline + usual post-operative medications
The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
干预措施: patient-reported pain scores (Behavioral)
Saline + usual post-operative medications
The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
干预措施: saline (Other)
结局指标
主要结局
number of patients that have moderate to severe pain
时间窗: up to 24 hours
Validated measures consisting of the Comparative Pain Scale and Simplified Postoperative Nausea and Vomiting (PONV) impact scale are currently administered to postoperative patients at JRSC. The Comparative pain scale ranges from 0-10, with 0 representing no pain and 10 representing the most severe pain. 0 = no pain 1-3 = minor pain 4-6 = moderate pain 7-10 = severe pain
次要结局
未报告次要终点