Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
研究概览
简要总结
The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.
详细描述
In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
时间窗: Up to 1 month
The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery
次要结局
- Time to first flatus(Up to 1 month)
- Overall benefit of analgesia score (OBAS)(Up to 1 month)
- Overall operating theatre time(Up to 10 hours)
- Post-operative morphine milligram equivalents recruitments(Up to 1 month)
- Time to post-operative mobilization(Up to 1 month)
- Visual analogue scale(Up to 1 month)
- Hospital readmission(30 and 90-day)
- Overall cost-effectiveness(Up to 6 months)
- Time to first bowel movement(Up to 1 month)
- Post-operative complications related to interventions according to Clavien-Dindo classification(30 and 90-day)
研究者
Heikki Huhta
Gastointestinal Surgeon, Adjunct Professor
Oulu University Hospital