Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
Colon cancer
The primary objective of the study is to evaluate, in patients undergoing surgery for colorectal cancer who receive either a lidocaine infusion or placebo, the difference in opioid analgesic consumption between the study groups within 24 hours after the surgical procedure
Key facts
- Sponsor
- Institute Of Oncology Ljubljana
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-10-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Institute of Oncology Ljubljana
External identifiers
- EU CT number
- 2025-521808-22-01
- ClinicalTrials.gov
- NCT06923787
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Prophylaxis, Safety
The primary objective of the study is to evaluate, in patients undergoing surgery for colorectal cancer who receive either a lidocaine infusion or placebo, the difference in opioid analgesic consumption between the study groups within 24 hours after the surgical procedure
Secondary objectives 1
- The secondary objective of the study is to evaluate, in patients undergoing surgery for colorectal cancer who receive either a lidocaine infusion or placebo, the effect of perioperative lidocaine infusion on the time to first postoperative bowel movement.
Conditions and MedDRA coding
Colon cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009944 | Colon cancer | 100000004864 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521808-22-00 | 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 | Institute Of Oncology Ljubljana |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Colon cancer of any stage, amenable for elective laparoscopic colon cancer resection with anastomosis
- age between 18 and 80 years old,
- low to medium risk of anasthesia complications (ASA up to and including 3),
- ability to understand the trial procedures and sign voluntary informed consent to participate in this trial
Exclusion criteria 16
- patients receiving neoadjuvant chemotherapy
- epilepsy
- active infection
- presence of viral or systemic fungal disease
- uncontrolled psychotic state
- ulcerative gastric or duodenum disease
- chronic corticosteroid therapy
- pregnancy and/or breastfeeding
- known allergy to lidocaine and other local anasthetics from amide group
- 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)
- Concurrent procedure on distant organs (e.g., liver metastases)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total opioid analgesic consumption in both groups during the first 24 hours after the surgical procedure, expressed in mg.
Secondary endpoints 1
- Time to first postoperative bowel movement in patients of both groups (measured in hours from the end of the surgical procedure).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Lidocaine Hydrochloride Monohydrate
SUB02922MIG · Substance
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1.0 mg/kg milligram(s)/kilogram
- Max total dose
- 1.0 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1000 ml millilitre(s)
- Max total dose
- 1000 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institute Of Oncology Ljubljana
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Institute Of Oncology Ljubljana
- Address
- Zaloska Cesta 2
- City
- Ljubljana
- Postcode
- 1000
- Country
- Slovenia
Scientific contact point
- Organisation
- Institute Of Oncology Ljubljana
- Contact name
- Nikola Bešić
Public contact point
- Organisation
- Institute Of Oncology Ljubljana
- Contact name
- Nikola Bešić
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Slovenia | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PILDI_Protokol klinicne raziskave_6junij2025 | 1 |
| Protocol (for publication) | PILDI_Protokol klinicne raziskave_9sept2025_FINAL | 2 |
| Protocol (for publication) | PILDI_Protokol klinicne raziskave_v2-1_22sept2025_FINAL | 2.1 |
| Protocol (for publication) | PILDI_Protokol klinicne raziskave_v3_3Mar2026_FINAL | 3 |
| Protocol (for publication) | PILDI_Protokol klinicne raziskave_v3_3Mar2026_Track changes | 3 |
| Recruitment arrangements (for publication) | PILDI_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | PILDI_v2_9-9-2025_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | PILDI_informacije za bolnike in soglasje_22Maj2025_FINAL | 1 |
| Subject information and informed consent form (for publication) | PILDI_Spremni dopis_Administrativne spremembe protokola in DPO_3Mar2026 | 1 |
| Subject information and informed consent form (for publication) | PILDI_v1_Obvestilo o menjavi DPO_3Mar2026 | 1 |
| Subject information and informed consent form (for publication) | PILDI_v2_9-9-2025_informacije za bolnike in soglasje_FINAL | 2 |
| Subject information and informed consent form (for publication) | PILDI_v3_03Mar2026_informacije za bolnike in soglasje_FINAL | 3 |
| Subject information and informed consent form (for publication) | PILDI_v3_03Mar2026_informacije za bolnike in soglasje_Track changes | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | 4a_Lidokain_SmPC | 1 |
| Synopsis of the protocol (for publication) | PILDI_Protocol summary_6Jun2025 | 1 |
| Synopsis of the protocol (for publication) | PILDI_Protokol klinicne raziskave_povzetek V2_9-9-2025 | 2 |
| Synopsis of the protocol (for publication) | PILDI_Protokol klinicne raziskave_povzetek_v2-1_22sept2025_FINAL | 2.1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-16 | Slovenia | Acceptable 2025-09-23
|
2025-10-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-05 | Slovenia | Acceptable 2025-09-23
|
2026-01-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-05 | Slovenia | Acceptable | 2026-01-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-16 | Slovenia | Acceptable 2026-02-04
|
2026-02-06 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-04 | Slovenia | Acceptable 2026-02-04
|
2026-03-04 |