Postoperative Pain After Laparoscopic Sleeve Gastrectomy: Comparison of Isolated Intravenous Analgesia, Epidural Analgesia Associated With Analgesia iv and Port-sites Infiltration With Bupivacaine Associated With Analgesia iv
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 主要终点
- Postoperative pain measured by Visual Analogic Scale
研究概览
简要总结
A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.
详细描述
A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.
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
- Single (Outcomes Assessor)
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
- •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
Port-sites infiltration:Bupivacaine0,25%
Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
干预措施: Metamizole and Acetaminophen iv (Drug)
Epidural analgesia:Levobupivacaine0.125%
Epidural analgesia consists in the placement of a thoracic epidural catheter inserted at the level T6-T7 and administration of a continuous perfusion of Levobupivacaine 0.125% 6ml/h.
Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
干预措施: Metamizole and Acetaminophen iv (Drug)
Metamizole and Acetaminophen iv
Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
干预措施: Metamizole and Acetaminophen iv (Drug)
结局指标
主要结局
Postoperative pain measured by Visual Analogic Scale
时间窗: 24 hours after surgery
Postoperative pain will be measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) 24 hours after surgery,
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
MD, PhD
Hospital General Universitario Elche