Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Average Daily In-Hospital Use of Opioids
研究概览
简要总结
The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic 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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Syringe with Obscuring Over-Wrap
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Robotic or Video-Assisted Lung Resection for All Indications
排除标准
- •Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
- •Extra-Thoracic Procedures
- •Hypersensitivity to Amide Local Analgesia
- •Cardiac Conduction Abnormalities
- •Hepatic Dysfunction
- •Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage
研究组 & 干预措施
Liposomal Bupivacaine
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
Drug Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc.
干预措施: Liposomal bupivacaine (Drug)
Standard Bupivacaine
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
Drug Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc.
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
Average Daily In-Hospital Use of Opioids
时间窗: Average over Entire Length of Hospitalization (Up to 1 Week)
Measured in Oral Morphine Equivalents per Day
次要结局
- Number of Participants With Postoperative Pneumonia(Index Hospitalization following Surgery until Discharge - Up to 1 Week)
- Average Daily In-Hospital Pain Score(Average over Length of Hospitalization - Up to 1 Week)
- Length of Stay(Index Hospitalization following Surgery until Discharge - Up to 1 Week)
研究者
Johannes R. Kratz, MD
Assistant Professor of Surgery Division of Adult Cardiothoracic Surgery; Van Auken Endowed Chair in Thoracic Oncology; Director, Minimally Invasive and Robotic Thoracic Surgery; Associate Director, Thoracic Surgery Residency Program
University of California, San Francisco