Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer S… (NCT07432399) | Clinical Trial Compass
RecruitingPhase 2
Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
Slovenia100 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha)
Timeframe: Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2.