Efficacy of Intercostal CryoAnalgesia in Patients Undergoing Robot Assisted Anatomic Lung Resection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS) Pain Score
研究概览
简要总结
This is a single center, single surgeon, prospective, randomized trial examining the addition of Cryo Nerve Block during robot assisted thoracoscopic anatomic lung resection surgery
详细描述
Thoracic surgical procedures are consistently reported to be among the most painful surgical incisions currently used. Trauma to the skin, muscle, intercostal nerves, bones and pleura all contribute and lead to activation of various pain pathways including somatic, visceral, neurogenic and phrenic. In the short term, this pain leads to ineffective cough and pulmonary hygiene resulting in respiratory complications and prolonged hospital stays while in the longer term it leads to prolonged recovery, delayed return to work and in some instances, chronic post thoracotomy pain syndromes. Minimally invasive approaches such as standard thoracoscopy or robotic assisted thoracoscopy have certainly decreased some of this trauma as evidenced by decreased length of stays and decreased complication rates however even with these minimally invasive techniques, recovery to 80% of baseline is 25 days and 9.4% of patients are still using narcotics after 90-180 days.
Several options are available in the management of pain following thoracic surgery with a multimodal pain medicine approach being most common. Opioids, unfortunately, are a relatively large part of this approach and are often relied upon despite their relatively unfavorable adverse event profile and risk for addiction. Many of the other pain adjuncts often used with thoracotomies such as epidural catheters or intraoperatively placed pain catheters are not really reasonable when using minimally invasive approaches as the hospital length of stay is 1-2 days. Intercostal cryoanalgesia has been shown to be a safe and effective strategy for postoperative pain management in patients undergoing thoracotomy. Recent studies have demonstrated the beneficial effect of cryoanalgesia for post-thoracotomy pain in reduction of opioid requirement, reduction in post-operative pain scores, and superior pulmonary function (higher FEV1 and FVC values)5 and that it can produce temporary neurolysis for up to two months without long-term histological nerve damage. To date it has not been studied when using minimally invasive techniques whether it be standard thoracoscopy or robotic assisted thoracoscopy but it would stand to reason that it would be equally or maybe more effective in this patient population and truly maximize the benefits of a minimally invasive approach.
We therefore propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe provides superior post-operative analgesia as compared to our current standard pain management strategy in patients undergoing robotic assisted thoracoscopic anatomic lung resection and allows for decreased opioid use and more rapid recovery.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years of age
- •Acceptable surgical candidate
- •Willing and able to return for scheduled follow-up visits
排除标准
- •Patients undergoing or requiring conversion to thoracotomy
- •Patients with chronic pain syndromes requiring treatment within the last year
- •Patients with a history of illicit drug use
- •Patients with a history of heavy alcohol use in the last five years as determined by the principal investigator
- •Patients currently using opioids
研究组 & 干预措施
Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control
Intercostal nerve cryoablation using the CryoICE® CRYOS-L cryoablation probe and an intercostal nerve block of nerves 4-9 performed using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin
干预措施: Intercostal Nerve Cryoablation (Device)
Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control
Intercostal nerve cryoablation using the CryoICE® CRYOS-L cryoablation probe and an intercostal nerve block of nerves 4-9 performed using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin
干预措施: Patient-controlled analgesia (PCA) (Drug)
Standard of Care (SOC) Pain Control
Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin
干预措施: Patient-controlled analgesia (PCA) (Drug)
结局指标
主要结局
Change in Visual Analogue Scale (VAS) Pain Score
时间窗: 14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180
The visual analogue scale is a pain assessment tool intended to help patient care providers assess pain according to individual patient needs. A 0-10 scale is used for patient self-assessment with 0 meaning no pain and 10 meaning worst possible pain.
Pain Medication Use
时间窗: 21 Days post-operatively
Patients will be asked about their pain medication use daily for 21 days following surgery. Total mg of postoperative pain medication taken will be collected.
次要结局
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score(Post-operative month 1, month 3, month 6)
- M.D. Anderson Symptom Inventory (MDASI) Score(Post-operative day 1, week 1, week 2, week 3, week 4, week 5, week 6)
- M.D. Anderson Symptom Inventory (MDASI) Score(Screening, Day 1, Day 7, Day 14, Day 21, Day 30, Day 35, Day 42)
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score(Screening, Day 30, Day 60, Day 180)
研究者
Mario Gasparri, MD
Professor
Medical College of Wisconsin