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临床试验/NCT03847363
NCT03847363Unknown不适用

The Influence of Different Anesthesia and Postoperative Pain Management on Acute and Chronic Postsurgical Pain After Thoracic Surgery: a Prospective Study

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
numerical rating scale of acute postsurgical pain

研究概览

简要总结

This study would compare acute and chronic postsurgical pain in patients underwent thoracic surgery with different anesthesia and analgesia methods, and explore the influencing factors.

详细描述

Chronic postsurgical pain (CPSP) was the pain caused by the operation that exceeded the healing time of normal tissue (usually 3 months), that was, a status that the damage caused by noxious stimulus had been healed, but the pain that cannot be explained by disease and inflammation were still existed. Due to the location of the incision and the necessity of indwelling the chest tube, the thoracic lung surgery was considered to be one of the most painful surgical operations. Studies have found that the incidences of CPSP in patients with thoracotomy were 57% (95% CI, 51-64%) and 47% (95% CI, 39-56%) at postoperative 3 and 6 months, respectively. With the development of minimally invasive techniques, thoracic surgery had gradually become less traumatic, and the number of surgical incisions was gradually developed into single port.Through ages, epidural analgesia with a combination of local anesthetics and opioids had long been considered the "gold standard" for postoperative analgesia in thoracic surgery. However, with the development of clinical anesthetics and the widespread use of nerve block techniques, it had been found that in open radical gastrectomy, there was no significant difference in the inhibition of intraoperative stress response between dexmedetomidine combined with general anesthesia and a combined general-epidural anesthesia. So, which anesthesia and analgesia method was "perfect" for a specific type of surgery procedure? This study would compare acute and chronic postsurgical pain in patients underwent different thoracic surgery procedure with different anesthesia and analgesia methods, and explore the influencing factors.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • underwent selective thoracic surgery

排除标准

  • with severe cardiac, endocrine,immunologic or haematologic diseases
  • medical history of chronic pain problems in chest area
  • medical history of pain-relief or sedative medication
  • not able to communicate with investigators

结局指标

主要结局

numerical rating scale of acute postsurgical pain

时间窗: at day2 post-operation

numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.

numerical rating scale of chronic postsurgical pain

时间窗: at 6th month post-operation

numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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