Colon CancerPhase 2PILDINCT07432399
Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
A Phase 2 study testing Lidocaine and Dexamethasone in people with Colon Cancer and Colorectal Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colorectal Cancer, Perioperative Immune Response
- What is being tested?
- Lidocaine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2025to 1 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older
- Histologically confirmed colon cancer
- Scheduled for elective surgical resection of colon cancer
- Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients
- Severe hepatic impairment
- Severe renal impairment
- Severe cardiac conduction disorders or clinically significant arrhythmias
- Pregnancy or breastfeeding
- Severe uncontrolled comorbidities that could interfere with study participation
- Participation in another interventional clinical trial that could influence study outcomes
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klavdija Korošec, 031 6300 65, kkorosec@onko-i.si
About this 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
This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.
Read the detailed description
This study is a prospective, randomized, double-blind, controlled phase II interventional clinical trial conducted at the Institute of Oncology Ljubljana. The trial investigates the effects of two perioperative pharmacological interventions-intravenous lidocaine infusion and high-dose dexamethasone-on postoperative immune response and clinical outcomes in patients undergoing surgical treatment for colon cancer.
Patients undergoing major oncologic surgery may develop significant perioperative immune suppression and inflammatory responses, which can influence postoperative recovery, complication rates, and overall outcomes. Lidocaine is known to have potential anti-inflammatory and immunomodulatory effects, while dexamethasone is widely used perioperatively for its anti-inflammatory properties. However, comparative evidence regarding their impact on postoperative immune response in colorectal cancer surgery is limited.
Eligible participants are adult patients with histologically confirmed colon cancer who are scheduled for surgical resection. After providing written informed consent, participants will be randomized in a double-blind manner to one of two study groups:
Perioperative intravenous lidocaine infusion group
High-dose perioperative dexamethasone group
Both interventions are administered according to the study protocol during the perioperative period. Randomization and masking ensure that participants, investigators, and clinical staff remain blinded to treatment allocation.
The primary objective of the study is to evaluate differences in postoperative immune response between the two intervention arms, assessed through laboratory immune and inflammatory markers. Secondary objectives include evaluation of postoperative clinical outcomes, such as postoperative recovery parameters and complications.
Participants are followed during the perioperative period and after surgery, and study assessments are performed according to the predefined schedule. This study will provide evidence regarding whether perioperative lidocaine infusion may offer beneficial immunological or clinical effects compared with high-dose dexamethasone in patients undergoing surgery for colon cancer. The results may support improved perioperative supportive care strategies and optimization of postoperative recovery in oncologic surgical patients.
- Being tested
- Lidocaine, Dexamethasone, Placebo
- Keywords
- PILDI, Lidocaine, Intravenous Lidocaine
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Perioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.
DexamethasoneDrug
High-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
PlaceboDrug
Perioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Infusion Group | Experimental | Participants receive perioperative intravenous lidocaine infusion in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures. Receives: Drug: Lidocaine |
| High-Dose Dexamethasone Group | Experimental | Participants receive perioperative high-dose intravenous dexamethasone in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures. Receives: Drug: Dexamethasone |
| Placebo Group | Placebo comparator | Participants receive perioperative intravenous placebo in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha)
Perioperative immune response is assessed by measuring serum inflammatory cytokine concentrations (IL-6, IL-8, IL-10, and TNF-alpha). Cytokine concentrations are compared between the lidocaine infusion group, the high-dose dexamethasone group, and the placebo group to evaluate differences in inflammatory response following colon cancer surgery.
Measured: Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2.
Secondary outcomes (4)
Total Opioid Consumption Within 24 Hours After Surgery
Total postoperative opioid consumption is assessed as the cumulative dose of opioid analgesics administered within the first 24 hours after surgery and compared between study groups.
Measured: First 24 hours after surgery.
Postoperative Pain Intensity Measured by the Visual Analogue Scale
Postoperative pain intensity is assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores are compared between study groups.
Measured: 2 hours after surgery and postoperative days 1 and 2.
Time to First Postoperative Bowel Movement
Time to first postoperative bowel movement is recorded as an indicator of gastrointestinal recovery and compared between study groups.
Measured: From end of surgery until first postoperative bowel movement (up to postoperative day 7).
Incidence of Postoperative Complications
Incidence of postoperative complications is assessed and compared between study groups, including surgical complications and adverse events potentially related to study medications.
Measured: From surgery through postoperative day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Sep 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (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
- Parallel-group randomized controlled trial with three study arms comparing perioperative intravenous lidocaine infusion, high-dose dexamethasone, and placebo in patients undergoing surgery for colon cancer.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432399
- Sponsor's protocol ID
- ORI2025-16
- Other IDs
- 2025-521808-22-00, 2025
- Acronym
- PILDI
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 6 Mar 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07432399
- Acronym / sponsor ID
- PILDI / ORI2025-16
- Keywords
- PILDI, Lidocaine, Intravenous Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 25 Feb 2026 (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.
This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.
Detailed description
This study is a prospective, randomized, double-blind, controlled phase II interventional clinical trial conducted at the Institute of Oncology Ljubljana. The trial investigates the effects of two perioperative pharmacological interventions-intravenous lidocaine infusion and high-dose dexamethasone-on postoperative immune response and clinical outcomes in patients undergoing surgical treatment for colon cancer.
Patients undergoing major oncologic surgery may develop significant perioperative immune suppression and inflammatory responses, which can influence postoperative recovery, complication rates, and overall outcomes. Lidocaine is known to have potential anti-inflammatory and immunomodulatory effects, while dexamethasone is widely used perioperatively for its anti-inflammatory properties. However, comparative evidence regarding their impact on postoperative immune response in colorectal cancer surgery is limited.
Eligible participants are adult patients with histologically confirmed colon cancer who are scheduled for surgical resection. After providing written informed consent, participants will be randomized in a double-blind manner to one of two study groups:
Perioperative intravenous lidocaine infusion group
High-dose perioperative dexamethasone group
Both interventions are administered according to the study protocol during the perioperative period. Randomization and masking ensure that participants, investigators, and clinical staff remain blinded to treatment allocation.
The primary objective of the study is to evaluate differences in postoperative immune response between the two intervention arms, assessed through laboratory immune and inflammatory markers. Secondary objectives include evaluation of postoperative clinical outcomes, such as postoperative recovery parameters and complications.
Participants are followed during the perioperative period and after surgery, and study assessments are performed according to the predefined schedule. This study will provide evidence regarding whether perioperative lidocaine infusion may offer beneficial immunological or clinical effects compared with high-dose dexamethasone in patients undergoing surgery for colon cancer. The results may support improved perioperative supportive care strategies and optimization of postoperative recovery in oncologic surgical patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel-group randomized controlled trial with three study arms comparing perioperative intravenous lidocaine infusion, high-dose dexamethasone, and placebo in patients undergoing surgery for colon cancer.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Infusion Group | Experimental | Drug: LidocaineParticipants receive perioperative intravenous lidocaine infusion in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures. |
| High-Dose Dexamethasone Group | Experimental | Drug: DexamethasoneParticipants receive perioperative high-dose intravenous dexamethasone in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants receive perioperative intravenous placebo in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older
- Histologically confirmed colon cancer
- Scheduled for elective surgical resection of colon cancer
- Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients
- Severe hepatic impairment
- Severe renal impairment
- Severe cardiac conduction disorders or clinically significant arrhythmias
- Pregnancy or breastfeeding
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 |
|---|---|---|
| LidocainePerioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care. | Drug | Lidocaine Infusion Group |
| DexamethasoneHigh-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery. | Drug | High-Dose Dexamethasone Group |
| PlaceboPerioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery. | Drug | Placebo Group |
Primary outcome
Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha)
Time frame: Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2.
Perioperative immune response is assessed by measuring serum inflammatory cytokine concentrations (IL-6, IL-8, IL-10, and TNF-alpha). Cytokine concentrations are compared between the lidocaine infusion group, the high-dose dexamethasone group, and the placebo group to evaluate differences in inflammatory response following colon cancer surgery.
4 secondary outcomes
Total Opioid Consumption Within 24 Hours After Surgery
Time frame: First 24 hours after surgery.
Postoperative Pain Intensity Measured by the Visual Analogue Scale
Time frame: 2 hours after surgery and postoperative days 1 and 2.
Time to First Postoperative Bowel Movement
Time frame: From end of surgery until first postoperative bowel movement (up to postoperative day 7).
Incidence of Postoperative Complications
Time frame: From surgery through postoperative day 30.
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 6 Mar 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.
1 site 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 and Dexamethasone in people with Colon Cancer and Colorectal Cancer, run by Institute of Oncology Ljubljana at 1 site 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 5 inclusion and 8 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nikola Bešić, MD, PhD (015879935, NBesic@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha) (time frame: Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2.). 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 6 Mar 2026.