Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 主要终点
- Post-operative Pain Day 3
研究概览
简要总结
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection. This is thought to be because of damage to the intercostal nerves by compression and traction by the surgical equipment. Cryoanalgesia is long-standing technique that freezes nerves locally to temporarily block pain sensation, which is currently used to treat acute post-operative pain in lung dissections and the Nuss procedure. We intend to perform a trial to assess whether using cryoanalgesia on intercostal nerves intraoperatively, reduces post-operative pain following minimally invasive cardiothoracic surgery.
详细描述
Objective:
To characterize the effects of peri-operative intercostal cryoablation for the prevention of post thoracotomy pain following minimally invasive mitral valve surgery or atrial septal defect repair.
Rationale:
Minimally invasive cardiothoracic surgery is often associated with prolonged post-operative neuropathic pain not consistent with the acute pain experience of the initial surgery [1]. This is often thought to be secondary to an intercostal neuralgia caused by traction injuries to the intercostal neurovascular bundles by the surgical ports, a mini-thoracotomy, and mechanical retraction of the ribs.
Cryoanalgesia is an older but clinically relevant technique that causes local destruction of nerve axons using a nitrous oxide-cooled probe to -60°C [2]. This allows for temporary acute pain relief without damaging the endoneurium, allowing the peripheral nerves to regrow post-operatively. Previous studies have demonstrated cryoanalgesia as having improved acute post-operative pain vs opioids alone or similar acute pain management vs epidural analgesia [3,4]. A few studies have assessed Cryoanalgesia in thoracic surgery patients; however, these studies have focused primarily on lung operations involving pulmonary resections, and did not include cardiac operations [5,6]. Furthermore, studies that evaluated cardiothoracic operations specifically, were either retrospective or prospective in approach and did not include a representative variety of cardiac operations [7-9]. Therefore, we hope that by using intercostal cryoablation in minimally invasive cardiac surgery patients, we might improve post-operative pain and reduce analgesic requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomized to either study group before surgery without the patient's knowledge of which group they are in. The surgeons (care providers) will need to be aware of the intervention so that they can supply the cryoanalgesia or not peri-operatively. The investigator and data analyst will also be blind to the intervention type when collecting patient outcome information and doing statistical analysis. Randomization will be documented in secure password protected databases that only the surgeons will have access too, matching patient identifiers to intervention groups for reference for final data presentation.
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
- •Adult patients aged 18 years or older scheduled for elective minimally invasive mitral valve surgery or atrial septal defect repair.
排除标准
- •Patients will be excluded if they are unable to fill in detailed health and pain related questionnaires, psychiatric disease preventing recall or accurate descriptions of pain, chronic pain syndromes, alcohol or illegal substance abuse, or pregnancy. Exclusion criteria also includes chronic use of opioids, allergy to morphine, bupivacaine, and/or ibuprofen, average pain during the last week >4 on a numerical rating scale from 0 to 10 with 0 indicating "no pain" and 10 indicating "the worst pain imaginable", contraindications to thoracic epidurals, prior chest surgery, or participation in another clinical trial.
研究组 & 干预措施
Intervention Group: Cryoanalgesia
Patients receiving cryoanalgesia peri-operatively during minimally invasive cardiothoracic surgery
干预措施: Atricure Inc. Nitrous oxide Cryoprobe (Device)
Control Group: No Cyroanalgesia
Patients receiving minimally invasive cardiothoracic surgery who do not receive cryoanalgesia.
结局指标
主要结局
Post-operative Pain Day 3
时间窗: 3 days post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Post-operative Pain Day 1
时间窗: 1 day post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Long-term Post-operative Pain
时间窗: 6 weeks post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory by asking the participants via phone call.
Post-operative Pain Day 5
时间窗: 5 days post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
次要结局
- Sleep Quality(1 week post-op)
- Long-term Consumptions of Analgesics(6 weeks post-op)
- Consumptions of Analgesics Day 1(1 day post-op)
- Consumptions of Analgesics Day 5(5 Days post-op)
- Consumptions of Analgesics Day 3(3 days post-op)
- Length of Hospital Stay(approximately 2 weeks post-op)