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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in opioid use in 24 hours after surgery between arms
研究概览
简要总结
There are very few data in the literature on changes in inflammatory markers when lidocaine is administered perioperatively in patients with colorectal cancer. In patients undergoing surgery for colon cancer, the aim is to conduct a double-blind placebo-controlled study to determine differences in levels of pro-inflammatory markers, postoperative pain and opioid analgesic consumption in the first two days after surgery, and the time to first postoperative bowel movement. Groups of patients receiving perioperative lidocaine infusion, high dose dexamethasone or placebo will be compared.
详细描述
In 80% of cancer patients, surgery is indicated during treatment. The choice of anasthetic technique can indirectly influence the patient's inflammatory and immune systems. Although a large body of data on the association between surgical stress and anasthesia in in vitro tumor models is already available, the importance of the individual drugs used during anasthesia on the inflammatory response and the post-operative course of patients is not yet fully understood, and further research is needed in this area.
There is increasing evidence that perioperative intravenous infusion of lidocaine has analgesic, prokinetic and anti-inflammatory properties in patients treated with surgical procedures. A significant number of studies have confirmed the positive effects of intravenous lidocaine infusion on reducing postoperative pain and reducing perioperative opioid consumption. In recent years, a growing number of studies have investigated the positive effects of lidocaine infusion on promoting peristalsis and faster recovery after surgery and on reducing the perioperative inflammatory response. This effect is also beneficial after colon surgery.
Inflammation is particularly detrimental in cancer patients as it may be associated with more frequent postoperative complications, slower recovery, and poorer cancer outcome (recurrence and/or survival), irrespective of the incidence of perioperative complications.
Surgical stress may promote tumor sequelae in several ways: ischemia and reperfusion injury, sympathetic nervous system activation, inflammation, systemic hypercoagulable state, immune suppression and the effects of anesthetics.
Proinflammatory markers, postoperative pain, opioid consumption, time to first postoperative bowel movement, and the effect on postoperative course in groups of patients receiving perioperative infusion of lidocaine or placebo have not yet been investigated in a double-blind placebo-controlled study. The data generated in this study may represent an important scientific contribution with a positive impact on the management of patients undergoing surgery for colon cancer.
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)
盲法说明
double-blind trial
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
- •colon cancer of any stage of the disease for which elective laparoscopic colon resection and colonic anastomosis will be performed,
- •age of patients between 18 and 80 years,
- •low to moderate risk of anesthesia (ASA up to and including 3),
- •ability to understand the study and to sign an informed consent to participate in the study
排除标准
- •patients receiving neoadjuvant chemotherapy,
- •pregnancy or breastfeeding,
- •known allergy to lidocaine
- •cardiac rhythm disturbances (bradycardia < 45 beats/min, complete heart block, use of group III antiarrhythmics),
- •status post cardiac arrest,
- •porphyria,
- •myasthenia gravis,
- •severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy),
- •renal disease (hamodialysis, creatinine clearance <30 mL/min),
- •epilepsy,
- •active infection,
- •presence of viral or systemic fungal disease,
- •uncontrolled psychotic state,
- •ulcerative gastric or duodenal disease,
- •chronic corticosteroid therapy.
研究组 & 干预措施
Lidokaine arm
Patients who will receive intravenous lidocaine.
干预措施: Lidocaine (Drug)
Placebo arm
Patients who will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in opioid use in 24 hours after surgery between arms
时间窗: 24 hours after surgery
Patients who receive a perioperative infusion of lidocaine will have lower need for opioid consumption oppose to placebo arm
次要结局
- Time to bowel movement after surgery(observation within 30 days after surgery)