Clinical trial · Interventional
Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
Effect of Perioperative Intravenous Infusion of Lidocaine or High Dose Dexamethasone on the Immune Response in Patients Undergoing Surgery for Colon Cancer - The PILDI Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Perioperative Immune Response | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lidocaine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Lidocaine Infusion Group
- description
- Participants receive perioperative intravenous lidocaine infusion in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
- interventionNames
- Drug: Lidocaine
- type
- EXPERIMENTAL
- label
- High-Dose Dexamethasone Group
- description
- Participants receive perioperative high-dose intravenous dexamethasone in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
- interventionNames
- Drug: Dexamethasone
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Ability to understand the study procedures and provide written informed consent Exclusion Criteria: * Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients * Severe hepatic impairment * Severe renal impairment * Severe cardiac conduction disorders or clinically significant arrhythmias * Pregnancy or breastfeeding * Severe uncontrolled comorbidities that could interfere with study participation * Participation in another interventional clinical trial that could influence study outcomes * Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation
References
Publications (0)
Data not yet available