A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?
研究概览
简要总结
We hypothesize that pregabalin will decrease post-operative pain scores and opioid use following abdominal hysterectomy compared to placebo. This study has been designed to determine if after an abdominal hysterectomy, the addition of pregabalin to their peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in terms of lower pain scores and reduced usage of opioids. The primary outcome will be post-operative pain, measured by total opioid consumption.
Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?
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
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesia physical status class I & II
- •Age > 18 years
- •English-speaking
- •Capability to operate a patient-controlled analgesia (PCA) device
排除标准
- •Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents)
- •Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- •History of a seizure disorder
- •Current therapy with pregabalin, gabapentin, or any opioid
- •Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
- •CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
Pregabalin 75 mg
干预措施: Pregabalin (Drug)
3
Pregabalin 150 mg
干预措施: Pregabalin (Drug)
结局指标
主要结局
Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?
时间窗: 1 year
次要结局
未报告次要终点
研究者
Ronald George
Primary Investigator, MD, FRCPC, Assistant Professor
IWK Health Centre