2025-521808-22-01招募中2 期
Effect of perioperative intravenous infusion of lidocaine on the postoperative course and the immune response in patients undergoing surgery for colon cancer - the PILDI study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total opioid analgesic consumption in both groups during the first 24 hours after the surgical procedure, expressed in mg.
研究概览
简要总结
The primary objective of the study is to evaluate, in patients undergoing surgery for colorectal cancer who receive either a lidocaine infusion or placebo, the difference in opioid analgesic consumption between the study groups within 24 hours after the surgical procedure
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Colon cancer of any stage, amenable for elective laparoscopic colon cancer resection with anastomosis
- •age between 18 and 80 years old,
- •low to medium risk of anasthesia complications (ASA up to and including 3),
- •ability to understand the trial procedures and sign voluntary informed consent to participate in this trial
排除标准
- •patients receiving neoadjuvant chemotherapy
- •cardiac rhythm disturbances (bradycardia < 45 beats/min, complete heart block, use of group III antiarrhythmics)
- •status post cardiac arrest
- •myasthenia gravis
- •severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy)
- •renal disease (hamodialysis, creatinine clearance <30 mL/min)
- •Concurrent procedure on distant organs (e.g., liver metastases)
- •active infection
- •presence of viral or systemic fungal disease
- •uncontrolled psychotic state
- •ulcerative gastric or duodenum disease
- •chronic corticosteroid therapy
- •pregnancy and/or breastfeeding
- •known allergy to lidocaine and other local anasthetics from amide group
结局指标
主要结局
Total opioid analgesic consumption in both groups during the first 24 hours after the surgical procedure, expressed in mg.
Total opioid analgesic consumption in both groups during the first 24 hours after the surgical procedure, expressed in mg.
次要结局
- Time to first postoperative bowel movement in patients of both groups (measured in hours from the end of the surgical procedure).
研究者
Nikola Bešić
Scientific
Institute Of Oncology Ljubljana
研究点 (1)
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