Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Mobilization measured daily using Cumulated Ambulation Score.
研究概览
简要总结
Effective treatment of pain after hip fractures is very important but difficult. It is often an old patient who has many adverse effects with the use of morphine.
This is a randomized pilot study where the investigators want to compare Norspan plaster to Oxycontin tablets to patients with particular kind of hip fractures. The investigators will evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No clinical study about the effect of Norspan as acute painkiller has never been done before. Can the investigators get the patients mobilized earlier with less adverse effects?
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
- •Males and females age 18 years or more
- •X-ray confirming basicervical, pertrochanteric or subtrochanteric femur fracture and planning operation with DHS or PFN.
- •Subjects must have 7 or more points in the Hindsøes test.
排除标准
- •Subjects where spinal anaesthesia cannot be applied.
- •Subject in Plavix® treatment seven days before admission to the hospital.
- •Subjects with extracapsular hip fracture due to bone metastasis.
- •Subjects with a BMI over
- •Subjects under 45 kg.
- •Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks prior admission to the hospital.
- •Substance or alcohol abuse, or subjects who, in the opinion of the investigator have demonstrated addictive or substance abuse behavior.
- •Untreated depression or other psychiatric disorder in such a way that participation in the study may in the opinion of the investigator pos an unacceptable risk to the subject.
- •Dermatological disorder at any relevant patch application site.
- •Any contraindications listed in the Summary of Product Characteristics for Norspan®, OxyNorm® and OxyContin®.
- •Patient does not tolerate oxynorm.
- •User of wheelchair.
- •Daily use of morphine before hospitalization.
- •More than one fracture. Patients with myasthenia gravis. Patients with severe respiratory function. Patients know need re-operation women of childbearing potential must have a negative pregnancy test and be non-lactating
研究组 & 干预措施
Buprenorphine
Double dummy; Group A: Active Buprenorphine and placebo oxycodone
干预措施: Buprenorphine (Drug)
Oxycodone
Double Dummy:
Group B: Placebo Buprenorphine and Active Oxycodone
干预措施: Oxycodone (Drug)
结局指标
主要结局
Mobilization measured daily using Cumulated Ambulation Score.
时间窗: 12 days
次要结局
- Length of stay in Hospital(Untill discharge)
- Adverse effects(12 days + 14 days)
- Pain intensity measured daily on a verbal rating scale(12 days)
- Opioid consumption.(12 days)