Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- The change in postoperative pain confirmed by Visual Analogue Pain Scale
研究概览
简要总结
The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
详细描述
Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity
排除标准
- •not done by VATS anatomical resection
- •patient does not agree to the study
- •postoperative hospital stay exceeds 7 days due to postoperative complications
- •existence of preoperative renal insufficiency (Cr > 1.5)
- •OT/PT > 120
- •history of Lidocaine hypersensitivity
研究组 & 干预措施
Bupivacaine
干预措施: Pre-emptive bupivacaine wound infiltration (Procedure)
Intravenous Patient Controlled Analgesia
postoperative pain control with intravenous patient controlled analgesia
干预措施: intravenous patient controlled analgesia (Procedure)
结局指标
主要结局
The change in postoperative pain confirmed by Visual Analogue Pain Scale
时间窗: Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months
次要结局
- number of participants with adverse events related to fentanyl or bupivacaine drug(2 months)
研究者
Sanghoon Jheon
Chief, Department of Thoracic and Cardiovascular Surgery
Seoul National University Bundang Hospital
