An Investigator-Initiated, Double-Blind, Patient-Controlled, Randomized Control Trial Comparing the Effectiveness of Liposomal Bupivacaine to a Solution of Bupivacaine, Epinephrine Clonidine and Dexamethasone in Bilateral, Single Shot, Erector Spinae Plane Blocks During Oncoplastic Breast Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pain Score at 48 hours
研究概览
简要总结
The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. This will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 75 years of age at screening
- •Scheduled to undergo oncoplastic bilateral mastectomy and reconstruction surgery at Tufts Medical Center
排除标准
- •Adults unable to consent (inability to read, write, or has some impairment that hampers consent process or documentation, or cognitively impaired adults)
- •Pregnant women
- •Pregnant minors
- •Woman of childbearing potential who are unwilling or unable to complete a pregnancy test
- •Minors i.e., individuals who are not yet adults (neonates, children, teenagers)
- •Wards of the state
- •Non-viable neonates
- •Neonates of uncertain viability
- •Adults with known allergy, hypersensitivity, intolerance or contraindication to study medication
研究组 & 干预措施
Control
Control arm will receive standard of care solution for the ESPB block
干预措施: Bupivacaine, epinephrine, dexamethasone, and clonidine (Drug)
Liposomal Bupivicaine
Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Pain Score at 48 hours
时间窗: 48 hours
Pain score will be recorded using a visual analogue scale (VAS) where 0 is no pain and 10 is unbearable pain. Pain will be recorded for the right and left side independently.
次要结局
- Pain Scores at 6, 12, 18, 24, 30, 38, 42, and 72 hours(72 hours)