Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study (PILDI)
Study Overview
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.
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 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 Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Eva Černe, MD
- Phone Number: 0038615879844
- Email: ecerne@onko-i.si
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- Recruiting
- Institute of Oncology Ljubljana
-
Contact:
- Nikola Bešić, MD, PhD
- Phone Number: 00386015879935
- Email: nbesic@onko-i.si
-
Ljubljana, Slovenia, 1000
- Not yet recruiting
- Institute of Oncology Ljubljana
-
Contact:
- Eva Černe, MD
- Phone Number: +386158799844
- Email: ecerne@onko-i.si
-
Principal Investigator:
- Nikola Bešić, MD
-
Sub-Investigator:
- Eva Černe, MD
-
Sub-Investigator:
- Branka Stražišar, MD
-
Sub-Investigator:
- Nina Kovačevič, MD
-
Sub-Investigator:
- Alojz Ihan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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,
- active infection,
- presence of viral or systemic fungal disease,
- uncontrolled psychotic state,
- ulcerative gastric or duodenal disease,
- chronic corticosteroid therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lidokaine arm
Patients who will receive intravenous lidocaine.
|
intravenous infusion of lidocaine
|
|
Placebo Comparator: Placebo arm
Patients who will receive placebo.
|
saline solution intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in opioid use in 24 hours after surgery between arms
Time Frame: 24 hours after surgery
|
Patients who receive a perioperative infusion of lidocaine will have lower need for opioid consumption oppose to placebo arm
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to bowel movement after surgery
Time Frame: observation within 30 days after surgery
|
Patients receiving a perioperative infusion of lidocaine will have a shorter time to first postoperative bowel movement than patients receiving placebo.
|
observation within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nikola Bešić, MD, Institute of Oncology Ljubljana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Colonic Diseases
- Colonic Neoplasms
- Organic Chemicals
- Anilides
- Amides
- Aniline Compounds
- Amines
- Acetanilides
- Lidocaine
Other Study ID Numbers
- ORI2025-016
- 2025-521808-22-01 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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