Intercostal Cryoanalgesia for Management of Acute 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
- Acute thoracic pain during cough
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 management of acute thoracic pain after VATS lung resection surgery.
详细描述
VATS lung resection is associated with a high incidence of moderate to severe acute thoracic pain. In the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications.
Regional analgesia techniques are usually recommended for VATS, and the paravertebral block is often used. However, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. At our institution, patients with VATS lung resections are often discharged home 24-48 hours after surgery.
Intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. Analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. These characteristics may allow rapid recovery and safe home discharge after VATS lung resection.
The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute 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)
- •Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine
- •Preoperative thoracic or shoulder pain on the operated side
- •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
Acute thoracic pain during cough
时间窗: 24 hours
Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)
次要结局
- Incidence of vomiting related to opioid consumption(7 days)
- QoR-15 score : 0 (worst) to 150 (best)(Preoperative and 48 hours postoperative)
- Time to hospital discharge(30 days)
- Evaluation of sedation related to opioid consumption(7 days)
- Acute thoracic pain at rest(1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days)
- Incidence of pruritus related to opioid consumption(7 days)
- Acute thoracic pain during cough(1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days)
- Postoperative morphine-equivalents consumption(7 days)
- Hypoesthesia over the ipsilateral thorax(24 hours)
- Incidence of nausea related to opioid consumption(7 days)