Clinical trial NCT06923787: Effect of Lidocaine or Dexamethasone on Cancer Immune Response- the PILDI Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Colon Cancer
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Inflammatory marker IL-8
timeFrame: 48 hours after surgery
measure: Changes in Inflammatory marker IL-17
timeFrame: 48 hours after surgery
measure: Changes in pain after surgery
timeFrame: 48 hours after surgery
measure: Opioid use after surgery
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Time to bowel movement after surgery
timeFrame: observation within 30 days after surgery
measure: Discharge to home care after surgery
timeFrame: within 30 days after surgery
measure: Changes in inflammatory marker IL-8
timeFrame: 48 hours after surgery
measure: Changes in inflammatory marker IL-17
timeFrame: 48 hours after surgery
measure: Changes in NK cells in cell culture
timeFrame: 48 hours after surgery
measure: Changes in T-lymphocytes in cell culture
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
Study officials:
affiliation: Institute of Oncology Ljubljana
name: Nikola Bešić, MD
role: PRINCIPAL_INVESTIGATOR
References: