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
Recruiting · NCT06923787 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Oncology Ljubljana
View the official record on ClinicalTrials.gov →Interventions studied
LidocainePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- Institute of Oncology Ljubljana - Ljubljana, Slovenia
- Institute of Oncology Ljubljana - Ljubljana, Slovenia