Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Total morphine dose
研究概览
简要总结
This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection.
There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.
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
- Single (Participant)
盲法说明
participants will be blinded to treatment group and will be sedated (part of standard of care surgery) at the time the treatment occurs
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 18 year and older.
- •Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy).
- •Performance status of 1 or 2.
排除标准
- •Patients with ejection fraction less than 40%
- •Patients with creatinine greater than 1.
- •Patients with Child's B or C cirrhosis
- •Patients on chronic narcotics for other reasons
- •Patients diagnosed with fibromyalgia
- •Patients who had previous thoracic surgery on the same side.
- •Patients who cannot communicate in English.
- •Patients unable to provide informed consent for the study.
研究组 & 干预措施
Cryoanalgesia with standard of care pain control
subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery
干预措施: cryoanalgesia (Device)
Cryoanalgesia with standard of care pain control
subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery
干预措施: Standard of Care Pain Control (Other)
Standard of care pain control
subjects will receive standard of care pain control only
干预措施: Standard of Care Pain Control (Other)
结局指标
主要结局
Total morphine dose
时间窗: to discharge (up to 14 days)
total milligrams (mg) of morphine received during hospitalization
Pain control
时间窗: to discharge (up to 14 days)
Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome
次要结局
- pulmonary complications(through 1 year)
- total morphine equivalent dose of narcotics(2 weeks and 3 months post-operatively)
- Incentive Spirometer Volume(to discharge (up to 14 days))
- pain control(2 weeks and 3 months post-operatively)
- Presence of neuropathy in the surgical site(2 weeks, 3 months, 6 months and 1 year postoperatively)
- Hospital length of stay(to discharge (up to 14 days))
研究者
Benny Weksler, MD
System Chief of Thoracic Surgery
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)