Clinical trial • Phase IV • Oncology
LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Colon cancer
Phase IV trial of LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Colon cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colon cancer
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-07-2025
- First CTIS Authorization Date
- 13-10-2025
Trial design
Placebo comparator: SODIUM CHLORIDE (solution for infusion) administered by intravenous infusion (product record shows max total dose amount 1000 ml). Test investigational product: LIDOCAINE HYDROCHLORIDE MONOHYDRATE administered by intravenous infusion (product record shows dose unit mg/kg with max daily dose amount 1.0 mg/kg). Specific randomisation method and schedule not specified in the provided record.-controlled Phase IV trial across 1 site in Slovenia.
- Comparator
- Placebo comparator: SODIUM CHLORIDE (solution for infusion) administered by intravenous infusion (product record shows max total dose amount 1000 ml). Test investigational product: LIDOCAINE HYDROCHLORIDE MONOHYDRATE administered by intravenous infusion (product record shows dose unit mg/kg with max daily dose amount 1.0 mg/kg). Specific randomisation method and schedule not specified in the provided record.
- Target Sample Size
- 100
Eligibility
Recruits 100 No vulnerable populations selected; participants must be able to understand the trial procedures and sign voluntary informed consent..
- Pregnancy Exclusion
- pregnancy and/or breastfeeding
- Vulnerable Population
- No vulnerable populations selected; participants must be able to understand the trial procedures and sign voluntary informed consent.
Inclusion criteria
- {"criterion_text":"- Colon cancer of any stage, amenable for elective laparoscopic colon cancer resection with anastomosis\n- age between 18 and 80 years old,\n- low to medium risk of anasthesia complications (ASA up to and including 3),\n- ability to understand the trial procedures and sign voluntary informed consent to participate in this trial"}
Exclusion criteria
- {"criterion_text":"- patients receiving neoadjuvant chemotherapy\n- cardiac rhythm disturbances (bradycardia < 45 beats/min, complete heart block, use of group III antiarrhythmics)\n- status post cardiac arrest\n- porphyria\n- myasthenia gravis\n- severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy)\n- renal disease (hamodialysis, creatinine clearance <30 mL/min)\n- Concurrent procedure on distant organs (e.g., liver metastases)\n- epilepsy\n- active infection\n- presence of viral or systemic fungal disease\n- uncontrolled psychotic state\n- ulcerative gastric or duodenum disease\n- chronic corticosteroid therapy\n- pregnancy and/or breastfeeding\n- known allergy to lidocaine and other local anasthetics from amide group"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Total opioid analgesic consumption in both groups during the first 24 hours after the surgical procedure, expressed in mg.","definition_or_measurement_approach":"Total opioid analgesic consumption measured during the first 24 hours after the surgical procedure, expressed in mg."}
Secondary endpoints
- {"endpoint_text":"- Time to first postoperative bowel movement in patients of both groups (measured in hours from the end of the surgical procedure).","definition_or_measurement_approach":"Measured in hours from the end of the surgical procedure until first postoperative bowel movement."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 17
- Consent Approach
- Voluntary informed consent required; inclusion requires ability to understand trial procedures and sign voluntary informed consent. Subject information and informed consent form documents are present (including Slovenian translation). No assent or parental consent procedures described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Slovenia
- Earliest CTIS Part Ii Submission Date
- 09-09-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 176
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Institute Of Oncology Ljubljana
- Department Name
- Surgery
- Principal Investigator Name
- Nikola Bešić
- Principal Investigator Email
- nbesic@onko-i.si
- Contact Person Name
- Nikola Bešić
- Contact Person Email
- nbesic@onko-i.si
- Number Of Participants
- 100
Sponsor
Primary sponsor
- Full Name
- Institute Of Oncology Ljubljana
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Slovenia
Investigational products
- Investigational Product Name
- LIDOCAINE HYDROCHLORIDE MONOHYDRATE
- Active Substance
- LIDOCAINE HYDROCHLORIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- marketingAuthNumber: -; prodAuthStatus: 2
- Maximum Dose
- 1.0 mg/kg (max daily dose amount per product record)
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- marketingAuthNumber: -; prodAuthStatus: 2
- Maximum Dose
- 1000 ml (max total dose amount per product record)
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