Colon CancerPhase 2PILDINCT06923787
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
A Phase 2 study testing Lidocaine in people with Colon Cancer, run by Institute of Oncology Ljubljana at 2 sites in Slovenia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesSlovenia
- Study dates
- 3 Feb 2026to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia2 sites, 2 recruiting
- Not yet recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Eva Černe, MD, +386158799844, ecerne@onko-i.si
Nikola Bešić, MD
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Nikola Bešić, MD, PhD, 00386015879935, nbesic@onko-i.si
About this study
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Lidocaine, Placebo
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
intravenous infusion of lidocaine
PlaceboDrug
saline solution intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Lidokaine arm | Active comparator | Patients who will receive intravenous lidocaine. Receives: Drug: Lidocaine |
| Placebo arm | Placebo comparator | Patients who will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in opioid use in 24 hours after surgery between arms
Patients who receive a perioperative infusion of lidocaine will have lower need for opioid consumption oppose to placebo arm
Measured: 24 hours after surgery
Secondary outcomes (1)
Time to bowel movement after surgery
Patients receiving a perioperative infusion of lidocaine will have a shorter time to first postoperative bowel movement than patients receiving placebo.
Measured: observation within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start3 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikola Bešić, MD, Principal investigator, Institute of Oncology Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923787
- Sponsor's protocol ID
- ORI2025-016
- Other IDs
- 2025-521808-22-01, 2025
- Acronym
- PILDI
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06923787
- Acronym / sponsor ID
- PILDI / ORI2025-016
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind randomized trial
| Arm | Type | Receives |
|---|---|---|
| Lidokaine arm | Active comparator | Drug: LidocainePatients who will receive intravenous lidocaine. |
| Placebo arm | Placebo comparator | Drug: PlaceboPatients who will receive placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaineintravenous infusion of lidocaine | Drug | Lidokaine arm |
| Placebosaline solution intravenous infusion | Drug | Placebo arm |
Primary outcome
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
1 secondary outcome
Time to bowel movement after surgery
Time frame: observation within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikola Bešić, MD principal investigator
Institute of Oncology Ljubljana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine in people with Colon Cancer, run by Institute of Oncology Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Černe, MD (0038615879844, ecerne@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in opioid use in 24 hours after surgery between arms (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.