Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older
Histologically confirmed colon cancer
Scheduled for elective surgical resection of colon cancer
Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol
Disqualifiers
Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients
Severe hepatic impairment
Severe renal impairment
Severe cardiac conduction disorders or clinically significant arrhythmias
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine
DrugPerioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.
Dexamethasone
DrugHigh-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
Placebo
DrugPerioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Lidocaine Infusion GroupExperimental treatment 1 intervention
Group B: High-Dose Dexamethasone GroupExperimental treatment 1 intervention
Group C: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha)
Perioperative immune response is assessed by measuring serum inflammatory cytokine concentrations (IL-6, IL-8, IL-10, and TNF-alpha). Cytokine concentrations are compared between the lidocaine infusion group, the high-dose dexamethasone group, and the placebo group to evaluate differences in inflammatory response following colon cancer surgery.
Time frame
Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2.Secondary outcomes
1
Total Opioid Consumption Within 24 Hours After Surgery
Total postoperative opioid consumption is assessed as the cumulative dose of opioid analgesics administered within the first 24 hours after surgery and compared between study groups.
Time frame
First 24 hours after surgery.2
Postoperative Pain Intensity Measured by the Visual Analogue Scale
Postoperative pain intensity is assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores are compared between study groups.
Time frame
2 hours after surgery and postoperative days 1 and 2.3
Time to First Postoperative Bowel Movement
Time to first postoperative bowel movement is recorded as an indicator of gastrointestinal recovery and compared between study groups.
Time frame
From end of surgery until first postoperative bowel movement (up to postoperative day 7).4
Incidence of Postoperative Complications
Incidence of postoperative complications is assessed and compared between study groups, including surgical complications and adverse events potentially related to study medications.
Time frame
From surgery through postoperative day 30.Other outcomes
1
Length of Hospital Stay
Length of hospital stay is assessed as the number of days from surgery until hospital discharge and compared between study groups.
Time frame
From surgery until hospital discharge (up to postoperative day 30).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov