IV lidocaine during colon cancer surgery to lower inflammation and speed recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial comparing perioperative intravenous lidocaine (and a comparator arm with high-dose dexamethasone) to placebo in adults undergoing elective laparoscopic colon resection with anastomosis. The study measures changes in pro-inflammatory markers, postoperative pain scores, opioid consumption in the first 48 hours, and time to first postoperative bowel movement. Eligible patients are adults 18–80 years old with colon cancer and ASA class up to 3, while those receiving neoadjuvant chemotherapy or with significant cardiac, hepatic, renal, neurologic, or infectious contraindications are excluded. The protocol is conducted at the Institute of Oncology Ljubljana with perioperative monitoring and blinded outcome assessment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Oncology Ljubljana
  Ljubljana, Slovenia Recruiting
• Institute of Oncology Ljubljana
  Ljubljana, Slovenia Not yet recruiting

Study contacts

• Principal investigator: Nikola Bešić, MD — Institute of Oncology Ljubljana
• Study coordinator: Eva Černe, MD
• Email: ecerne@onko-i.si
• Phone: 0038615879844

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.