NCT06923787RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Apr 2025
- Start date
- 3 Feb 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Colorectal cancer
- NCT number
- NCT06923787
- EU CT number
- 2025-521808-22-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 3 Feb 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients receiving neoadjuvant chemotherapy,
- chronic corticosteroid therapy.
Other illness
- known allergy to lidocaine
- cardiac rhythm disturbances (bradycardia \< 45 beats/min, complete heart block, use of group III antiarrhythmics),
- status post cardiac arrest,
- severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy),
- epilepsy,
- active infection,
- presence of viral or systemic fungal disease,
- ulcerative gastric or duodenal disease,
Lab values
- renal disease (hamodialysis, creatinine clearance \<30 mL/min),
Other
- pregnancy or breastfeeding,
- porphyria,
- myasthenia gravis,
- uncontrolled psychotic state,
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.