Lidocaine or dexamethasone around colon cancer surgery and the body's immune response
Compares lidocaine and dexamethasone given during colon cancer surgery, looking at immune response.
Plain-language title generated from the registry record
Registry title: Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
Key facts
- Where
- Ljubljana, SloveniaSee the site
- Phase
- Phase 2
Where in Slovenia
- Institute of Oncology LjubljanaLjubljana, SloveniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Oncology Ljubljana
- Trial code
- NCT07432399EU 2025-521808-22-00
- Record updated
- 6 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients; Severe hepatic impairment; Severe renal impairment; Severe cardiac conduction disorders or clinically significant arrhythmias; Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation; Pregnancy or breastfeeding; Severe uncontrolled comorbidities that could interfere with study participation; Participation in another interventional clinical trial that could influence study outcomes.