Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Status and phase: Not yet enrolling; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Epidural ropivacaine; Drug: Intravenous lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04449289

43/3.02.2020

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intravenous lidocaine

Active Comparator group

Description:

Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative

Treatment:

Drug: Intravenous lidocaine

Epidural ropivacaine

Active Comparator group

Description:

Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively

Treatment:

Drug: Epidural ropivacaine