Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale pain scores
研究概览
简要总结
This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing robotic wedge resection or lobectomy for lung mass(es)
排除标准
- •emergency case
- •history of opiate abuse
- •chronic pain syndrome
- •intravenous drug use
- •chronic use of oral steroids
- •pregnancy
- •imprisonment
- •body weight lower than 70 kg
- •liver failure
- •uninsured patients
- •non-verbal patients or patients who are unable to rate their pain on a visual analogue pain scale
- •history of allergic reaction to any of the drugs used in the study: bupivacaine, liposomal bupivacaine, dexamethasone
研究组 & 干预措施
Bupivacaine/epinephrine + dexamethasone
干预措施: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone (Drug)
Liposomal bupivacaine
干预措施: Intercostal nerve block and wound infiltration with liposomal bupivacaine (Drug)
结局指标
主要结局
Visual Analogue Scale pain scores
时间窗: 24 hours post-surgery
Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior.
次要结局
未报告次要终点
研究者
Kingsuk Ganguly, M.D.
Assistant Professor of Anesthesiology
The Cooper Health System