Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score One Hour After Surgery
研究概览
简要总结
Effect of nicotine patch as an adjutant for acute pain after surgery.
详细描述
This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ASA 1-2
排除标准
- •Cardiovascular disease
- •Former smoker
研究组 & 干预措施
Smokers-nicotine
Smokers who were treated with nicotine
干预措施: nicotine patch (Drug)
Nonsmokers-nicotine
Nonsmokers who were treated with nicotine
干预措施: nicotine patch (Drug)
Smokers-placebo
Smokers who were treated with placebo
干预措施: placebo (Drug)
Nonsmokers-placebo
Nonsmokers who were treated with placebo
干预措施: placebo (Drug)
结局指标
主要结局
Postoperative Pain Score One Hour After Surgery
时间窗: 1 hour after surgery
Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.
Postoperative Pain Score Five Days After Surgery
时间窗: 5 days
Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.
次要结局
- Nausea Assessment by Patient(1 hour after surgery)
- Heart Rate(1 hour after surgery)
- Pain Medication Used(5 days)
- Systolic Blood Pressure(1 hour after surgery)
- Diastolic Blood Pressure(1 hour after surgery)