NCT01577940已完成4 期
Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers
Glostrup University Hospital, Copenhagen4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
研究概览
简要总结
The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 30 years
- •written consent
- •BMI between 18 and 25
排除标准
- •unable to communicate in Danish
- •relevant drug allergy
- •alcohol or/and drug abuse
- •daily intake of prescription pain medication the last 4 weeks
- •pain medication in the last 48 hours
- •previously operated abdominal
结局指标
主要结局
Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
时间窗: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Extent of sensory block using pinprick and ice
次要结局
- Heat pain detection threshold (abdomen)(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)
- Heat pain detection threshold (dominant forearm)(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)
- Long Thermal stimulation (abdomen)(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)
- Lung function(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)
研究者
Pernille Lykke Petersen
Principal investigator
Glostrup University Hospital, Copenhagen
研究点 (4)
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