RecruitingPhase 2NCT06923787

Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study


Sponsor

Institute of Oncology Ljubljana

Enrollment

100 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

There are very few data in the literature on changes in inflammatory markers when lidocaine is administered perioperatively in patients with colorectal cancer. In patients undergoing surgery for colon cancer, the aim is to conduct a double-blind placebo-controlled study to determine differences in levels of pro-inflammatory markers, postoperative pain and opioid analgesic consumption in the first two days after surgery, and the time to first postoperative bowel movement. Groups of patients receiving perioperative lidocaine infusion, high dose dexamethasone or placebo will be compared.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether giving the local anaesthetic lidocaine through a drip (IV infusion) during and after colon cancer surgery can speed up recovery and reduce the immune system's stress response to surgery. **You may be eligible if...** - You have colon cancer of any stage and are scheduled for planned (non-emergency) keyhole (laparoscopic) surgery - You are between 18 and 80 years old - Your anaesthetic risk is low to moderate (ASA score 1–3) - You are able to understand the study and give consent **You may NOT be eligible if...** - You are receiving pre-surgery (neoadjuvant) chemotherapy - You are pregnant or breastfeeding - You have a known allergy to lidocaine - You have a serious heart rhythm problem, recent cardiac arrest, or porphyria (a rare blood disorder) - You have severe liver problems or kidney disease requiring dialysis Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGLidocaine

intravenous infusion of lidocaine

DRUGPlacebo

saline solution intravenous infusion


Locations(2)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Institute of Oncology Ljubljana

Ljubljana, Slovenia

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NCT06923787


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