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临床试验/EUCTR2015-000992-28-SI
EUCTR2015-000992-28-SI进行中(未招募)不适用

A comparison of the severity of acute pain and the frequency of chronic pain after post-operative analgesia of lower and higher intensity following surgical emptying of the axillary gland in breast cancer patients in relation to the pharmacogenomics in the metabolism of tramadol – a prospective, double blind, randomised clinical trial

Krka, d.d., Novo mesto0 个研究点开始时间: 2015年6月10日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • - Surgical emptying of the axillary gland in breast cancer patients.
  • - Age of the patients between 18 and 70 years.
  • - Signed on the voluntary consent of the patient.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • - the simultaneous reconstruction of the breast tissue extender or free lobe;
  • - hypersensitivity to the drug used in the study (a local anesthetic, piritramide, tramadol, naproxen, acetaminophen, pantoprazole);
  • - the male gender;
  • - pregnancy;
  • - a high risk because of anesthesia (ASA above 3);
  • - under the age of 18 years and above 70;
  • - liver and kidney disease;
  • - participants taking drugs that may have affect on the outcome of treatment (other analgesics, drugs for the treatment of central nervous system);
  • - the presence of a psychiatric disease (dementia, schizophrenia, manic-depressive illness).

研究者

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