NCT06923787 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
| NCT ID | NCT06923787 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2026-02-03 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Nikola Bešić, MD
PRINCIPAL INVESTIGATOR
Institute of Oncology Ljubljana
Frequently Asked Questions
Who can join the NCT06923787 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06923787 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06923787 currently recruiting?
Yes, NCT06923787 is actively recruiting participants. Contact the research team at ecerne@onko-i.si for enrollment information.
Where is the NCT06923787 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia, Ljubljana, Slovenia.
Who is sponsoring the NCT06923787 clinical trial?
NCT06923787 is sponsored by Institute of Oncology Ljubljana. The principal investigator is Nikola Bešić, MD at Institute of Oncology Ljubljana. The trial plans to enroll 100 participants.
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