Effect of Lidocaine or Dexamethasone on Cancer Immune Response- the PILDI Study

Phase 3

Not yet recruiting

• Conditions: Colon Cancer
• Interventions: Drug: Lidocaine; Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT06923787
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

There are very few data in the literature on changes in inflammatory markers when lidocaine or corticosteroids are 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.

Detailed Description

In 80% of cancer patients, surgery is indicated during treatment. The choice of anasthetic technique can indirectly influence the patient's inflammatory and immune systems. Although a large body of data on the association between surgical stress and anasthesia in in vitro tumor models is already available, the importance of the individual drugs used during anasthesia on the inflammatory response and the post-operative course of patients is not yet fully understood, and further research is needed in this area.

There is increasing evidence that perioperative intravenous infusion of lidocaine has analgesic, prokinetic and anti-inflammatory properties in patients treated with surgical procedures. A significant number of studies have confirmed the positive effects of intravenous lidocaine infusion on reducing postoperative pain and reducing perioperative opioid consumption. In recent years, a growing number of studies have investigated the positive effects of lidocaine infusion on promoting peristalsis and faster recovery after surgery and on reducing the perioperative inflammatory response. This effect is also beneficial after colon surgery.

Corticosteroids are also increasingly used perioperatively as they reduce the exaggerated perioperative inflammatory response. The importance of lidocaine infusion or corticosteroids and associated inflammatory frequency and proinflammatory markers on the postoperative course in colon cancer patients is not yet fully understood.

Inflammation is particularly detrimental in cancer patients as it may be associated with more frequent postoperative complications, slower recovery, and poorer cancer outcome (recurrence and/or survival), irrespective of the incidence of perioperative complications.

Surgical stress may promote tumor sequelae in several ways: ischemia and reperfusion injury, sympathetic nervous system activation, inflammation, systemic hypercoagulable state, immune suppression and the effects of anesthetics.

Proinflammatory markers, postoperative pain, opioid consumption, time to first postoperative bowel movement, and the effect on postoperative course in groups of patients receiving perioperative infusion of lidocaine, dexamethasone, or placebo have not yet been investigated in a double-blind placebo-controlled study. The data generated in this study may represent an important scientific contribution with a positive impact on the management of patients undergoing surgery for colon cancer.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-11-01
• Primary Completion: 2027-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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,
• allergy to dexamethasone,
• active infection,
• presence of viral or systemic fungal disease,
• uncontrolled psychotic state,
• ulcerative gastric or duodenal disease,
• chronic corticosteroid therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidokaine arm	Lidocaine	Patients who will receive intravenous lidocaine.
Lidokaine arm	Placebo	Patients who will receive intravenous lidocaine.
Dexamethasone arm	Dexamethasone	Patients who will receive dexamethasone.
Dexamethasone arm	Placebo	Patients who will receive dexamethasone.
Placebo arm	Placebo	Patients who will receive placebo.

Primary Outcome Measures

Name	Time	Method
Changes in Inflammatory marker IL-8	48 hours after surgery	Patients who receive a perioperative infusion of lidocaine or dexamethasone will have lower levels of the pro-inflammatory marker IL-8 in the first 48 hours after surgery than patients who receive placebo.
Changes in Inflammatory marker IL-17	48 hours after surgery	Patients who receive a perioperative infusion of lidocaine or dexamethasone will have lower levels of the pro-inflammatory marker IL-17 in the first 48 hours after surgery than patients who receive placebo.
Changes in pain after surgery	48 hours after surgery	Patients who receive a perioperative infusion of lidocaine or dexamethasone will have less pain (as measured by the VAS scale) in the first 48 hours after surgery than patients who receive a placebo.
Opioid use after surgery	48 hours after surgery	Patients receiving a perioperative infusion of lidocaine or dexamethasone will have lower opioid consumption in the first 48 hours after surgery than patients receiving placebo.

Secondary Outcome Measures

Name	Time	Method
Time to bowel movement after surgery	observation within 30 days after surgery	Patients receiving a perioperative infusion of lidocaine or dexamethasone will have a shorter time to first postoperative bowel movement than patients receiving placebo.
Discharge to home care after surgery	within 30 days after surgery	Patients who receive a perioperative infusion of lidocaine or dexamethasone will be discharged to home care sooner than patients who receive a placebo.
Changes in inflammatory marker IL-8	48 hours after surgery	Patients receiving a perioperative infusion of dexamethasone will have lower levels of the pro-inflammatory markers IL-8 in the first 48 hours after surgery than patients receiving an infusion of lidocaine.
Changes in inflammatory marker IL-17	48 hours after surgery	Patients receiving a perioperative infusion of dexamethasone will have lower levels of the pro-inflammatory markers IL-8 in the first 48 hours after surgery than patients receiving an infusion of lidocaine.
Changes in NK cells in cell culture	48 hours after surgery	A greater proportion of patients receiving a perioperative infusion of dexamethasone than those receiving an infusion of lidocaine will have a reduced cytotoxic capacity of NK cells in cell culture in the first 48 hours after surgery.
Changes in T-lymphocytes in cell culture	48 hours after surgery	A greater proportion of patients receiving a perioperative infusion of dexamethasone than those receiving an infusion of lidocaine will have a reduced cytotoxic capacity of NK cells in cell culture in the first 48 hours after surgery.

Trial Locations

Locations (1)

Institute of Oncology Ljubljana; 🇸🇮 Ljubljana, Slovenia