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临床试验/NCT01701921
NCT01701921已完成2 期

The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery

Larissa University Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
opioid consumption and other analgesics after surgery

研究概览

简要总结

The purpose of this study is to determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery.

详细描述

Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and anxiolytic properties and was also used to treat neuropathic pain. In recent years it has been used as part of a multimodal management of acute postoperative pain after various types of surgery. We study the effect of pregabalin administered before cardiac surgery on acute and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various analgesic methods have been used from time to time (opioids, regional analgesia, non-steroidal anti-inflammatory drugs). In our research patients will be divided into three groups. The control group will receive a placebo capsule before surgery. The second group will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale (0-10) every day. Total morphine consumption by the patients as well as any other pain medications administered supplementary will be registered and compared between the different groups. Remaining postoperative pain will be assessed after 3 months. The results will be statistically analyzed in order to determine whether there is significant difference in pain management between the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' age 18-85years who are undergoing cardiac surgery

排除标准

  • Chronic pain syndromes
  • Renal failure
  • Allergy to Pregabalin
  • Patients already taking pregabalin

研究组 & 干预措施

Pregabalin 75

Experimental

Pregabalin 75mg by mouth one hour before surgery

干预措施: Pregabalin 75mg (Drug)

Pregabalin 150

Active Comparator

Pregabalin 150mg by mouth one hour before surgery

干预措施: pregabalin 150 mg (Drug)

Sugar pill

Placebo Comparator

Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery

干预措施: Placebo (Drug)

结局指标

主要结局

opioid consumption and other analgesics after surgery

时间窗: 24 hours after surgery

Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded.

次要结局

  • Remaining surgery related pain and analgesics consumption(3 months after surgery)

研究者

发起方
Larissa University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aikaterini Bouzia

MD

Larissa University Hospital

研究点 (1)

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