IV lidocaine during colon cancer surgery to lower inflammation and speed recovery
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
This trial will test if an intravenous lidocaine infusion given around the time of surgery can lower inflammation, reduce pain and opioid use, and help bowel function recover faster in adults having laparoscopic colon cancer surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Ljubljana and 1 other locations) |
| Trial ID | NCT06923787 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 with colon cancer scheduled for elective laparoscopic colon resection and colonic anastomosis, ASA class ≤3, who are not receiving neoadjuvant chemotherapy and can provide informed consent.
Not a fit: Patients who are pregnant or breastfeeding, receiving neoadjuvant chemotherapy, or who have excluded conditions such as significant cardiac arrhythmias, severe liver or renal disease, epilepsy, or other listed contraindications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, perioperative IV lidocaine could reduce inflammation and pain, lower opioid requirements, speed return of bowel function, and shorten early recovery after colon cancer surgery.
How similar studies have performed: Multiple prior studies in general surgical populations have shown that perioperative IV lidocaine can reduce postoperative pain, opioid use, and speed return of bowel function, but data specifically linking lidocaine to immune marker changes and cancer outcomes are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ljubljana and 1 other locations
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Not_yet_recruiting)
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: Nikola Bešić, MD — Institute of Oncology Ljubljana
- Study coordinator: Eva Černe, MD
- Email: ecerne@onko-i.si
- Phone: 0038615879844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.