Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
研究概览
简要总结
The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain.
Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.
详细描述
The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. Pregabalin (S-aminomethyl-5-methylhexaninacid) is a further development of gabapentin. Pregabalin has a fewer side-effects compared with gabapentin.
The purpose of this study is to compare the analgetic and anxiolytic effect of pregabalin and placebo used as premedication.
The hypothesis is that a single-dose pregabalin (150 mg postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo.
The study is including patients undergoing surgery of the vertebral columna.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of disc prolapse
- •ASA (American Association in Anesthesiology) I-III
- •written consent
排除标准
- •Age < 18
- •ASA > III
- •liver failure
- •renal failure
- •allergic reaction against gabapentin and/or pregabalin
- •pregnancy
研究组 & 干预措施
Pregabalin
150 mg Pregabalin per orally about one hour before surgery
干预措施: pregabalin (Drug)
Pregabalin
150 mg Pregabalin per orally about one hour before surgery
干预措施: morphine (Drug)
Placebo
One capsule of saccharose (placebo) was administered orally about one hour before surgery.
干预措施: Placebo (Drug)
Placebo
One capsule of saccharose (placebo) was administered orally about one hour before surgery.
干预措施: morphine (Drug)
结局指标
主要结局
Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
时间窗: 120 minutes after surgery
The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.
次要结局
- Morphine (Opioid) Consumption Cumulated(240 minutes)