NCT00600899Unknown4 期
Use of Home Pumps for Analgesia After Ambulatory Foot Surgery - Comparison of Two Infusion Rates - a Randomized, Double-Blind Study
Frederiksberg University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- worst pain
研究概览
简要总结
The purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery.
详细描述
Protocol title:
Use of home pumps for analgesia after ambulatory foot surgery - comparison of two infusion rates SUMMARY in English
THE PURPOSE:
The purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery.
BACKGROUND:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ambulatory patients (ASA 1-3) scheduled for foot and ankle surgery in spinal or general anesthesia that are willing to participate in the study after informed consent will be taken into consideration.
- •Age span: 19 -80 years.
- •When fertile females are included, we will make sure that they receive anticonceptive treatment.
排除标准
- •Contraindications for sciatic catheter placement and allergy to local anesthetics.
- •The patients with chronic pain receiving opioids, pregnant patients, those with rheumatoid arthritis, lever or heart disease.
结局指标
主要结局
worst pain
时间窗: first postoperative day
次要结局
- Average pain(1st, 2nd and 3rd postoperative days)
- Opioid consumption(first, second and third postoperative days)
- Side effects(1st, 2nd and 3rd postoperative days)
研究者
研究点 (2)
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