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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients

Severe hepatic impairment

Severe renal impairment

Severe cardiac conduction disorders or clinically significant arrhythmias

Trial design

Treatments tested in this trial

  • Lidocaine
  • Dexamethasone
  • Placebo

Treatment groups

100 Participants
are divided into 3 treatment groups