Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.
详细描述
Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be undergoing minimally invasive thoracic surgery
- •Patients who will be undergoing minimally invasive thoracic surgery
排除标准
- •Open surgery
- •Chronic use of narcotics
- •Use of pregabalin or similar
- •Significant liver or kidney dysfunction
研究组 & 干预措施
Bupivacaine with epinephrine
Patients will receive intraoperative intercostal nerve block with bupivacaine
干预措施: Bupivacaine / Epinephrine (Drug)
Lipossomal extended release bupivacaine
Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine
干预措施: Bupivacaine liposome (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 3-5 days post op
Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.
次要结局
- Narcotic used(3-5 days post op)
- Postoperative complications(90 days post op)
研究者
Benny Weksler
Professor of Surgery
University of Tennessee