Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 主要终点
- Pain
研究概览
简要总结
A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline (Control Group - CG).
详细描述
A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).
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
- 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 with the presence of comorbidities associated to obesity.
排除标准
- •patients undergoing other bariatric techniques or revisional surgery
- •allergy to local anesthetics
- •severe underlying cardiovascular diseases
- •chronic renal failure
- •hepatic dysfunction
- •previous foregut surgery
- •patients with any contraindication for bariatric surgery.
研究组 & 干预措施
Ropivacaine irrigation
Using a standard irrigation device, 300 mg total of ropivacaine in 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces.
干预措施: Ropivacaine irrigation (Drug)
Normal saline irrigation
Using a standard irrigation device, 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces.
干预措施: Normal saline irrigation (Drug)
结局指标
主要结局
Pain
时间窗: 24 hours postoperatively
Postoperative pain will be evaluated by a blinded nurse 24 hours after surgery. Pain will be quantified using a visual analogic scale (VAS), ranging from 0(absence of pain) to 10 (unbearable pain).
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Principal investigator
Hospital General Universitario Elche