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.
This study is a prospective, randomized, double-blind, controlled phase II interventional clinical trial conducted at the Institute of Oncology Ljubljana. The trial investigates the effects of two perioperative pharmacological interventions-intravenous lidocaine infusion and high-dose dexamethasone-on postoperative immune response and clinical outcomes in patients undergoing surgical treatment for colon cancer. Patients undergoing major oncologic surgery may develop significant perioperative immune suppression and inflammatory responses, which can influence postoperative recovery, complication rates, and overall outcomes. Lidocaine is known to have potential anti-inflammatory and immunomodulatory effects, while dexamethasone is widely used perioperatively for its anti-inflammatory properties. However, comparative evidence regarding their impact on postoperative immune response in colorectal cancer surgery is limited. Eligible participants are adult patients with histologically confirmed colon cancer who are scheduled for surgical resection. After providing written informed consent, participants will be randomized in a double-blind manner to one of two study groups: Perioperative intravenous lidocaine infusion group High-dose perioperative dexamethasone group Both interventions are administered according to the study protocol during the perioperative period. Randomization and masking ensure that participants, investigators, and clinical staff remain blinded to treatment allocation. The primary objective of the study is to evaluate differences in postoperative immune response between the two intervention arms, assessed through laboratory immune and inflammatory markers. Secondary objectives include evaluation of postoperative clinical outcomes, such as postoperative recovery parameters and complications. Participants are followed during the perioperative period and after surgery, and study assessments are performed according to the predefined schedule. This study will provide evidence regarding whether perioperative lidocaine infusion may offer beneficial immunological or clinical effects compared with high-dose dexamethasone in patients undergoing surgery for colon cancer. The results may support improved perioperative supportive care strategies and optimization of postoperative recovery in oncologic surgical patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Perioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.
High-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
Perioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
Institute of Oncology Ljubljana
Ljubljana, Slovenia
RECRUITINGChange 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.
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.
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.
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).
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.
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