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临床试验/NCT01703351
NCT01703351已完成2 期

Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2012年10月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
79
试验地点
1
主要终点
1. Acute pain

研究概览

简要总结

Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy and it has reduced the operative morbidities and mortalities. However, thoracoscopic lobectomy also results in operative acute pain and the incidence of chronic pain after thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar, torque at trocar and working window by operator, and compression of intercostal nerves have been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous patient-controlled analgesia (IV PCA) that usually have used to control the operative pain, sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might reduce the side effects of IV PCA and control the operative pain effectively. In this study, we investigate the effectiveness of continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.

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 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age; 18≥, <75
  • Thoracoscopic lobectomy due to lung cancer or suspected lung cancer
  • Tolerable cardiopulmonary and other systemic function tolerable to lobectomy
  • Karnofsky performance status ≥ 80
  • Agree with study

排除标准

  • Intolerable to one-lung ventilation
  • Bleeding risk due to Aspirin, coumadin and other drugs
  • Past or current history of depression or other psychiatric disease
  • Pain persisted before operation due to lung lesion
  • History of rib fracture, trauma or lung surgery at the same side of operation
  • Severe pleural adhesion or empyema
  • Open thoracotomy conversion
  • Reoperation due to postoperative bleeding or others
  • Postoperative complications that need ICU care
  • Chemical pleurodesis more than two times after operation
  • Do not agree with study

研究组 & 干预措施

Drug: 0.5% ropivacaine

Experimental

干预措施: 0.5% ropivacaine (Drug)

Fentanyl 500mcg + acupan 160mg + nasea 0.6mg

Active Comparator

干预措施: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg (Drug)

结局指标

主要结局

1. Acute pain

时间窗: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)

次要结局

  • 2. Quality of life(measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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