RecruitingPhase 2NCT07432399

Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)

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

Sponsor

Institute of Oncology Ljubljana

Enrollment

100 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether giving lidocaine (a local anaesthetic) or high-dose dexamethasone (a steroid) around the time of colon cancer surgery can reduce inflammation and improve immune function during recovery. **You may be eligible if...** - You are 18 or older - You have colon cancer confirmed by biopsy - You are scheduled for planned (elective) surgical removal of your colon cancer - You are able to understand the study and provide written consent **You may NOT be eligible if...** - You have a known allergy to lidocaine, dexamethasone, or related medications - You have serious heart, liver, or kidney problems that would make the study drugs unsafe - Your surgery is being done as an emergency - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLidocaine

Perioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.

DRUGDexamethasone

High-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.

DRUGPlacebo

Perioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.