RecruitingPhase 2

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

Slovenia100 participantsStarted 2026-02-03

Plain-language 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.

Who can participate

Age range

18 Years – 80 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: * colon cancer of any stage of the disease for which elective laparoscopic colon resection and colonic anastomosis will be performed, * age of patients between 18 and 80 years, * low to moderate risk of anesthesia (ASA up to and including 3), * ability to understand the study and to sign an informed consent to participate in the study Exclusion Criteria: * patients receiving neoadjuvant chemotherapy, * pregnancy or breastfeeding, * known allergy to lidocaine * cardiac rhythm disturbances (bradycardia \< 45 beats/min, complete heart block, use of group III antiarrhythmics), * status post cardiac arrest, * porphyria, * myasthenia gravis, * severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy), * renal disease (hamodialysis, creatinine clearance \<30 mL/min), * epilepsy, * active infection, * presence of viral or systemic fungal disease, * uncontrolled psychotic state, * ulcerative gastric or duodenal disease, * chronic corticosteroid therapy.

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

Difference in opioid use in 24 hours after surgery between arms

Timeframe: 24 hours after surgery

Trial details

NCT IDNCT06923787

SponsorInstitute of Oncology Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Eva Černe, MD

0038615879844 ecerne@onko-i.si

View on ClinicalTrials.gov More Colon Cancer trials