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临床试验/NCT00129597
NCT00129597Unknown4 期

Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年12月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
40
试验地点
2
主要终点
To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy

研究概览

简要总结

Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain is related to a sensitization of the central nervous system through N-methyl-D-asparate (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA properties after mastectomy.

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
Double

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mastectomy in patients 18 to 80 years old

排除标准

  • American Society of Anesthesiology (ASA) class >= 3
  • Renal, heart or hepatic failure
  • Allergy to ketalar
  • Psychiatric disease
  • Chronic antalgic treatment

结局指标

主要结局

To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy

Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.

次要结局

  • To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia

研究者

申办方类型
Other

研究点 (2)

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