Laparoscopic-guided Transversus Abdominis Plane (TAP) Block for Postoperative Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
A prospective randomized trial will be performed. Patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and morphine needs will be quantified.
详细描述
A prospective randomized trial will be performed. Patients undergoing laparoscopic Roux-en-Y gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided TAP block with 30 ml Bupivacaine 0.5%, as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h), and patients receiving only postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h) (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24 hours after surgery and morphine needs will be quantified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient and nursery staff evaluating postoperative pain do not know the applied intervention.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) >40 Kg/m2
- •BMI >35 Kg/m2 and obesity associated comorbidities
- •Patients undergoing laparoscopic Roux en Y gastric bypass
排除标准
- •Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass
- •Patients undergoing open bariatric surgery
研究组 & 干预措施
Metamizol iv
The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain.
干预措施: Metamizol iv (Drug)
TAP block
The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain.
干预措施: Metamizol iv (Drug)
TAP block
The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain.
干预措施: TAP block (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 24 hours after surgery
Pain quantification will be assessed with a Visual Analogic Scale
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Head of Department of Research in Bariatric Surgery
Hospital General Universitario Elche