跳至主要内容
临床试验/NCT01704469
NCT01704469已完成不适用

A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients

Yonsei University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Post-injection pain intensity

研究概览

简要总结

Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but conflicting. Previous clinical studies mostly used experimental or non-standardized surgical stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized, clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • age 20-80
  • cancer patient
  • patient whom receiving opioid treatment, any acute or chronic pain condition amenable to a diagnostic/therapeutic nerve block or neuromodulation,and a regular analgesic regimen.

排除标准

  • patient who has any change in opioid or other analgesic medications less than 14 days prior to the scheduled procedure
  • an inability to understand English or adequately respond to the relevant questions

结局指标

主要结局

Post-injection pain intensity

时间窗: 1 min after lidocaine anesthetic injection

The local anesthetic injection before main procedure was performed by one pain physician using a 25-gauge needle and 1 ml of 1% lidocaine to raise a small skin wheel. Before and immediately following the injection, patients were asked to rate injection-specific pain and unpleasantness intensity on a 0 to 10 numerical rating scale (NRS).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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