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临床试验/NCT01748435
NCT01748435Unknown不适用

The Role of Pre-emptive Analgesia With Qutenza (Topical Capsaicin 8%) in Preventing Neuropathic Pain Following Lower Limb Amputation: a Pilot Randomised Controlled Study

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Chronic neuropathic pain

研究概览

简要总结

Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit protheses and mobilise. Current treatment options are limited and existing painkillers have significant side effects. Nevertheless there is some evidence that pre-emptive analgesia (pain relief provided prior to the surgery) has additional benefits after the surgery (Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is applied directly onto the skin. It works by desensitising to pain receptors in the skin (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot, randomised controlled study of 30 patients undergoing lower limb amputation who will have Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks post-operatively with regular assessment of pain scores, quality of life and wound healing.

研究设计

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

入排标准

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

入选标准

  • All adult patients >18 years old undergoing lower limb amputation

排除标准

  • Traumatic amputation Severe active sepsis in non-viable limb Illness necessitating urgent surgery <24 hours after admission to hospital Hypersensitivity to Qutenza, Emla or any of the excipients Broken skin or active ulceration at the site of application Severe uncontrolled hypertension (systolic BP >200) Proven cardiac event during the preceding 3 months Women who are pregnant or breast feeding Lack of capacity or inability to provide informed consent Declines participation in the study

研究组 & 干预措施

Qutenza

Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch

干预措施: Qutenza (Drug)

结局指标

主要结局

Chronic neuropathic pain

时间窗: 12 weeks

Chronic neuropathic pain as assessed by Visual Analogue Pain Score

次要结局

  • Neuropathic pain(1 weeks, 6 weeks, 12 weeks)
  • Acute post-operative pain(Day 1, 3, 7)
  • Wound healing(1 week)
  • Quality of life(12 weeks)
  • Safety and tolerability(1 day, 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma Aitken

Clinical Resrach Fellow

NHS Greater Glasgow and Clyde

研究点 (1)

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