A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
研究概览
简要总结
We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score 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
- — 至 65 Years（Child, 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 ¬< 65 years
- •English-speaking
- •Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)
排除标准
- •Known or suspected allergy, sensitivity, or contraindication to pregabalin
- •Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
- •Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- •History of a seizure disorder
- •Current pre-operative therapy with pregabalin, gabapentin, or any opioid
- •Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative 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
干预措施: Pregabalin 150 mg (Drug)
结局指标
主要结局
The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
时间窗: 24 hours
次要结局
- NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation(48 hours)
研究者
Ronald George
Primary Investigator, MD, FRCPC, Assistant Professor
IWK Health Centre