NCT01052285已完成4 期
The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery.
Glostrup University Hospital, Copenhagen2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年6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
- 90
- 试验地点
- 2
- 主要终点
- Pain scores by coughing between TAP block group and placebo group
研究概览
简要总结
The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •groin hernia repair
- •written consent
- •BMI 18-35
排除标准
- •unable to communicate in Danish
- •relevant drug allergy
- •pain medication in the last 24 hours
- •pregnancy
- •alcohol or/and drug abuse
- •daily opioid intake
- •infection at injection site
结局指标
主要结局
Pain scores by coughing between TAP block group and placebo group
时间窗: 0,2,4,6,8,19 and 24 hours postoperative
Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,19,24 hours postoperative
次要结局
- Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.(0,2,4,6,8,19 and 24 hours postoperative)
- Total opioid consumption(0-24 hours postoperative)
- Postoperative nausea and vomiting(0,2,4,6,8,19,24 hours postoperative)
- Sedation(0,2,4,6,8,19,24 hours postoperative)
- Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo(0,2,4,6,8,19,24 hours postoperative)
研究者
Pernille Lykke Petersen
MD
Glostrup University Hospital, Copenhagen
研究点 (2)
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