Effect of Perioperative Intravenous Infusion of Lidocaine or High Dose Dexamethasone on 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
- 1
- 主要终点
- Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha)
研究概览
简要总结
This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.
详细描述
This study is a prospective, randomized, double-blind, controlled phase II interventional clinical trial conducted at the Institute of Oncology Ljubljana. The trial investigates the effects of two perioperative pharmacological interventions-intravenous lidocaine infusion and high-dose dexamethasone-on postoperative immune response and clinical outcomes in patients undergoing surgical treatment for colon cancer.
Patients undergoing major oncologic surgery may develop significant perioperative immune suppression and inflammatory responses, which can influence postoperative recovery, complication rates, and overall outcomes. Lidocaine is known to have potential anti-inflammatory and immunomodulatory effects, while dexamethasone is widely used perioperatively for its anti-inflammatory properties. However, comparative evidence regarding their impact on postoperative immune response in colorectal cancer surgery is limited.
Eligible participants are adult patients with histologically confirmed colon cancer who are scheduled for surgical resection. After providing written informed consent, participants will be randomized in a double-blind manner to one of two study groups:
Perioperative intravenous lidocaine infusion group
High-dose perioperative dexamethasone group
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind design: participants, care providers, investigators, and outcome assessors are blinded to treatment allocation. Study medication is prepared and labeled in an identical manner to maintain blinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older
- •Histologically confirmed colon cancer
- •Scheduled for elective surgical resection of colon cancer
- •Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients
- •Severe hepatic impairment
- •Severe renal impairment
- •Severe cardiac conduction disorders or clinically significant arrhythmias
- •Pregnancy or breastfeeding
- •Severe uncontrolled comorbidities that could interfere with study participation
- •Participation in another interventional clinical trial that could influence study outcomes
- •Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation
研究组 & 干预措施
Lidocaine Infusion Group
Participants receive perioperative intravenous lidocaine infusion in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
干预措施: Lidocaine (Drug)
High-Dose Dexamethasone Group
Participants receive perioperative high-dose intravenous dexamethasone in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
干预措施: Dexamethasone (Drug)
Placebo Group
Participants receive perioperative intravenous placebo in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha)
时间窗: Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2.
Perioperative immune response is assessed by measuring serum inflammatory cytokine concentrations (IL-6, IL-8, IL-10, and TNF-alpha). Cytokine concentrations are compared between the lidocaine infusion group, the high-dose dexamethasone group, and the placebo group to evaluate differences in inflammatory response following colon cancer surgery.
次要结局
- Total Opioid Consumption Within 24 Hours After Surgery(First 24 hours after surgery.)
- Postoperative Pain Intensity Measured by the Visual Analogue Scale(2 hours after surgery and postoperative days 1 and 2.)
- Time to First Postoperative Bowel Movement(From end of surgery until first postoperative bowel movement (up to postoperative day 7).)
- Incidence of Postoperative Complications(From surgery through postoperative day 30.)