Clinical trial · Interventional
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
- 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)
There are very few data in the literature on changes in inflammatory markers when lidocaine is 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.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lidocaine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lidokaine arm
- description
- Patients who will receive intravenous lidocaine.
- interventionNames
- Drug: Lidocaine
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- Patients who will receive placebo.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Difference in opioid use in 24 hours after surgery between arms
- timeFrame
- 24 hours after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available