Intercostal Cryoanalgesia for Prevention of Chronic Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Incidence of persistent thoracic pain
研究概览
简要总结
Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the prevention of chronic thoracic pain after VATS lung resection surgery.
详细描述
VATS lung resection is associated with a high incidence of persistent thoracic pain. To our knowledge, there is no study on the effect of cryoanalgesia on the incidence and severity of chronic thoracic pain 3 months after VATS lung resection.
Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. In a recent study by Ilfeld & al, intercostal cryoanalgesia (combined with a single-injection paravertebral block) was able to drastically lower the incidence of chronic pain after total mastectomy compared to the use of the paravertebral block alone (3% vs 17%).
The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia for the prevention of chronic thoracic pain after VATS lung resection 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple
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 scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by VATS for lung cancer
- •American Society of Anesthesiologists (ASA) score 1-3
排除标准
- •Contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space)
- •Contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia)
- •Epidural analgesia preferred (high risk of thoracotomy, marginal lung function)
- •Surgical criteria (conversion to thoracotomy, non anatomical wedge resection)
- •Preoperative thoracic or shoulder pain on the operated side
- •Known allergy to acetaminophen, celecoxib, sulfa, or both hydromorphone and morphine
- •History of thoracic surgery on the operated site
- •Regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine)
- •Inability to understand pain scales or to communicate clearly despite adequate teaching
- •Contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate < 60 mL/min, active gastric ulcer)
- •Pregnancy
- •Patient refusal to participate
结局指标
主要结局
Incidence of persistent thoracic pain
时间窗: 3 months
Persistent postoperative thoracic pain (yes or no)
次要结局
- Incidence of persistent opioid consumption(1,3 and 6 months)
- Incidence of postoperative neuropathic pain(48 hours, 1 month and 6 months)
- Incidence of new prescription for neuropathic pain medication(1, 3 and 6 months)
- Persistent hypoesthesia over the ipsilateral thorax(1 and 6 months)
- Incidence of persistent thoracic pain(1 and 6 months)
- Severity of persistent thoracic pain(1,3 and 6 months)