Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Post-operative Opioid Use
研究概览
简要总结
The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.
详细描述
Patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a Transabdominal Plane Block injection or a placebo saline injection. The injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. Patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. Patients in both arms are medically cleared by the surgeon. Currently there are no studies that look at the use of Transabdominal Plane Block in ventral hernia repairs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •age 18 and older
- •elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount Sinai Hospital
排除标准
- •age younger than 18
- •allergic reaction to bupivacaine
- •allergic reaction to opioids
- •opioid substance abuse
研究组 & 干预措施
Transabdominal Plane Block
Receiving Transabdominal Plane Block with 0.25% bupivacaine
干预措施: Transabdominal Plane Block (Drug)
Non Transabdominal Plane Block
Receiving placebo saline injection
干预措施: Non Transabdominal Plane Block (Drug)
结局指标
主要结局
Post-operative Opioid Use
时间窗: up to 24 hours
Amount of opioids used by patients at certain time points.
次要结局
- Operating Procedure Time(Procedure begin time to procedure end time)
- Pain Score(24 hours postoperatively)
研究者
Celia M. Divino
Professor
Icahn School of Medicine at Mount Sinai