NCT01463865已完成不适用
Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial
Hillerod Hospital, Denmark1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
In this study the investigators wish to compare the effect of a selective axillary nerve block to placebo in patients undergoing arthroscopic shoulder surgery.
It is the investigators hypothesis that the amount of morphine consumption in the first 4 hours postoperatively in the intervention group will be significant lower than in the placebo group.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing arthroscopic shoulder surgery
- •Age between 18 and 80 years
- •BMI between 18 and 35 kg/m2
- •Subjects which have given their written informed consent
排除标准
- •Subjects unable to cooperate to the investigation
- •Subjects not understanding or speaking danish
- •Subjects allergic to intervention drugs
- •Daily use of strong analgesics (morphine, oxycontine, ketogan)
- •Alcohol or medicine misuse
- •Failure of nerve block
研究组 & 干预措施
Placebo
Placebo Comparator
Sodium chloride
干预措施: Sodium chloride (Drug)
ropivacaine
Active Comparator
Naropin
干预措施: ropivacaine (Drug)
结局指标
主要结局
Morphine consumption
时间窗: 0-4 hours postoperatively
Patients are coupled to an intravenous PCA pump. The amount of morphine administered by the patient in the first 4 hours postoperatively is registered.
次要结局
- Visual analogue scale (VAS) score(0-12 hours and 12-24 hours postoperatively)
- Escape block(0-4 hours postoperatively)
- Postoperative nausea and vomiting (PONV)(0-4, 0-12 and 12-24 hours postoperatively)
- Total morphine consumption(0-24 hours postoperatively)
- Bolus morphine 5 mg iv(0-4 hours postoperatively)
研究者
Kai Henrik Wiborg Lange
Head of research, Associate professor, phd
Hillerod Hospital, Denmark
研究点 (1)
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