Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Pericicatricial hyperalgesia area
研究概览
简要总结
In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.
详细描述
Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •ASA status 1 - 3
- •Colorectal laparoscopic surgery with piece removal
- •French speaking
- •Written informed consent
排除标准
- •laparoscopy without colorectal extraction
- •chronic pain
- •analgesic consumption during the 24 hours previous to the surgery
- •morphine and LA intolerance
- •drug addiction
- •inflammatory bowel disease
- •general inflammatory disease
- •anemia < 10 gr/dl
- •liver or renal or cardiac insufficiency
- •uncontrolled diabetes
- •preoperative consumption of opiate/corticosteroid/beta-blockers, and anti-arrhythmic drugs, MAOIs, neuroleptics.
- •preoperative consumption of NSAIDs excluding aspirin referred cardiology
研究组 & 干预措施
2
Patients with intravenous lidocaine infusion
干预措施: parenteral analgesia combining acetaminophen and morphine (Drug)
3
Patients without local anesthetics
干预措施: parenteral analgesia combining acetaminophen and morphine (Drug)
1
Patients with continuous ropivacaine preperitoneal infusion
干预措施: continuous ropivacaine preperitoneal infusion (Drug)
1
Patients with continuous ropivacaine preperitoneal infusion
干预措施: parenteral analgesia combining acetaminophen and morphine (Drug)
2
Patients with intravenous lidocaine infusion
干预措施: intravenous lidocaine infusion (Drug)
3
Patients without local anesthetics
干预措施: NaCl (Drug)
结局指标
主要结局
Pericicatricial hyperalgesia area
时间窗: 72 hours after surgery
次要结局
- Pain intensity (rest/mobilization and long-term)(72 hours, 3 months and 6 months after surgery)
- Morphine consumption(During 5 days after surgery)