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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

RECRUITINGPhase 2Sponsored by Institute of Oncology Ljubljana
Actively Recruiting
PhasePhase 2
SponsorInstitute of Oncology Ljubljana
Started2026-02-03
Est. completion2027-07-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions2

CancerColon Cancer

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