Visceral Pain Originating From the Upper Urinary Tract - a Randomized Controlled Trial on the Effect of Morphine and Oxycodone in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Amount of analgetics used
研究概览
简要总结
The purpose of this study is to investigate the effect of oxynorm versus morphine after operation for kidney stone (PCNL). In addition the relationship between pain symptoms and referred sensory and trophic changes will be examined in the patients before and after the operation.Finally a blood sample is analysed to investigate pharmaca-genetics.
详细描述
Primary outcome: the amount of opioid (morphine or oxynorm) used the first 4 hours postoperatively.
Secondary outcome: side effect to the opioids, pain score, pain threshold to electrical stimulation and pressure before and after operation, pharmacogenetics, size of referred pain area.
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
- •Age > 18
- •Indication for PCNL
排除标准
- •Malignant disease in the upper urinary tract
- •Allergy to morphine or oxycodone
- •Use of opioids the last 48 hours before PCNL
- •Pregnancy
- •Nursing mothers
- •Present JJ-stent in the ureter
- •Previous urinary stone disease on the opposite site
研究组 & 干预措施
oxycodone
干预措施: oxycodone (Drug)
morphine
干预措施: morphine (Drug)
结局指标
主要结局
Amount of analgetics used
时间窗: four hours postoperatively
次要结局
- Side effects(four hours postoperatively)
研究者
Katja venborg Pedersen
MD
Fredericia Hosptial