Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
Overview
- Phase
- Phase 2
- Intervention
- Intravenous lidocaine
- Conditions
- Pancreatic Cancer
- Sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1- and 3-years recurrence rate after surgery
- Status
- Not Yet Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Theodor Bot
PhD student
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Eligibility Criteria
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
Arms & Interventions
Intravenous lidocaine
Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative
Intervention: Intravenous lidocaine
Epidural ropivacaine
Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively
Intervention: Epidural ropivacaine
Outcomes
Primary Outcomes
1- and 3-years recurrence rate after surgery
Time Frame: 3 years
Study participants will be contacted by study team via phone or e-mail
Secondary Outcomes
- Complication rate after surgery(2 weeks)
- 1- and 3-years survival after surgery(3 years)
- Lidocaine and ropivacaine concentration(Intraoperatively)