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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Colon Cancer

In brief

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.

Key facts

Study ID

NCT06923787

Run by

Institute of Oncology Ljubljana

People needed

100

Starts

2026-02-03

Expected to finish

2028-07-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Institute of Oncology Ljubljana — Ljubljana, Slovenia (enrolling)
• Institute of Oncology Ljubljana — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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