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临床试验/NCT00938171
NCT00938171Unknown3 期

A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial

Mackay Memorial Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
3 期
入组人数
40
试验地点
2
主要终点
Visual Analog Scale (VAS) pain scores

研究概览

简要总结

The purpose of this study is to determine therapeutic benefits by local anesthetic technique for breast cancer.

详细描述

Experimental and clinical studies have shown that surgical trauma and stress affects the immune system including both the innate and adaptive immune responses.

The break of immune homeostasis might enhance tumor growth and spread. Minimal invasive surgical procedures have been shown to be beneficial to patients in terms of preserving better systemic immune function. Impaired cellular immunity after general anesthesia has significant undesirable effects on tumor surveillance after breast surgery. The local block technique might avoid the surgery inducing neuroendocrine, metabolic, and cytokine responses, which will offer some advantages from better preservation of early postoperative cellular immune function and attenuate disturbance in the inflammatory mediators. Our research will focus on the effects of local block anesthesia on mediators that may be important in inflammatory response, tumor cell dissemination, deposition, and propagation in the early postoperative period. As importantly, local block method is not only a safe procedure but also reduces the need for post operative opioids and prevents nausea following breast cancer which can result in markedly reduced hospital stay and health costs. It is plausible that inhibition of the surgical responses by local block anesthesia may attenuate perioperative tumor enhancing factors and/or potential beneficial actions of lidocaine infiltration combined with propofol sedation per se in anticancer effect to have better cancer control.

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 (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Biopsy-proven breast cancer Scheduled for mastectomy and axillary node dissection in a single procedure.

排除标准

  • previous surgery within the preceding 2 wk those other than ASA physical status I or II any contraindication to either local anesthesia or opioid analgesia

结局指标

主要结局

Visual Analog Scale (VAS) pain scores

时间窗: Until PACU discharge and for 24 hours

次要结局

  • disease free survival(5 years)
  • Episodes of nausea or vomiting(24 hours)
  • Overall patient satisfaction(After hospital discharge and six months later)
  • The need for postoperative opioids(24 hours)

研究者

申办方类型
Other

研究点 (2)

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