Effects of Perioperative Belladonna and Opium Suppositories on Postoperative Pain and Morphine Consumption on Patients After Robotic Assisted Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Pain Assessment by Visual Analog Scale at Rest
研究概览
简要总结
This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50% of patients will not. Neither you or your surgeon will know which group you are in.
详细描述
All patients undergoing LRP at Virginia Mason Medical Center between November 1, 2008 and July 30, 2009 were offered the opportunity to participate in a randomized double blind clinical trial. Operating surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Post-operative pain was assessed by a visual analog scale (VAS) and post-operative narcotic use was calculated in intravenous morphine equivalents.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic radical prostatectomy at Virginia Mason, who do not have chronic pain or allergies to opioid analgesics are eligible for this study.
排除标准
- •Women are excluded due to the absence of a prostate.
- •Children are excluded due to the absence of prostate cancer in this group.
- •Patients meeting any of the following will not be eligible for the study:
- •Patients at risk for complications from anticholinergic agents including those with a history of glaucoma, bronchial asthma, convulsive disorder, or high risk for delirium
- •History of previous allergies or adverse reactions to belladonna and opium and/or opioid analgesics
- •History of chronic pain or chronic use of opioid and nonopioid analgesics
- •History of alcohol or opioid dependency/abuse within last three months
研究组 & 干预措施
B & O suppository
B & O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)
干预措施: belladonna 16.2 mg and opium 60 mg suppository (Drug)
结局指标
主要结局
Pain Assessment by Visual Analog Scale at Rest
时间窗: 24 hours
The Pain Assessment by Visual Analog Scale (VAS) consists of 100 millimeter (mm) horizontal line with two endpoints 1-100, labeled "no pain" and "worst possible pain. "No pain" is the minimum value and "worst possible pain" is the maximum value. Minimum value or "No Pain" is considered a better outcome.
次要结局
未报告次要终点
研究者
John Corman, MD
Principal Investigator
Benaroya Research Institute