Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
Phase 2
Not yet recruiting
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT04449289
- Lead Sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Brief Summary
Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.
As short term endpoints: postoperative complications and resumption of bowel function.
Long term endpoints include: 1 and 3 year recurrence and mortality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- diagnosis of pancreatic cancer
- American Society of Anesthesiologists (ASA) risk I - III
Exclusion Criteria
- chronic pain
- chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
- contraindications for any of the study medications
- significant psychiatric disorders (major depression, bipolar disorders, schizophrenia, etc.)
- Convulsive disorders requiring medication during the last 2 years
- liver cirrhosis/chronic kidney disease stage IV or V/chronic heart failure class III or IV/ decompensated diabetes
- Corticoid dependent asthma
- Autoimmune disorders
- Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
- Refusal for study participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous lidocaine Intravenous lidocaine Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative Epidural ropivacaine Epidural ropivacaine Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively
- Primary Outcome Measures
Name Time Method 1- and 3-years recurrence rate after surgery 3 years Study participants will be contacted by study team via phone or e-mail
- Secondary Outcome Measures
Name Time Method Complication rate after surgery 2 weeks Resumption of bowel function, anastomotic leakage or hemorrhage
1- and 3-years survival after surgery 3 years Study participants will be contacted by study team via phone or e-mail
Lidocaine and ropivacaine concentration Intraoperatively
Trial Locations
- Locations (1)
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
🇷🇴Cluj-Napoca, Romania