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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Intravenous lidocaine
* Drug: Epidural ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous lidocaine<br>Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative | Drug: Intravenous lidocaine<br>* Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia<br>|
| Active Comparator: Epidural ropivacaine<br>Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively | Drug: Epidural ropivacaine<br>* Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- and 3-years recurrence rate after surgery | Study participants will be contacted by study team via phone or e-mail | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- and 3-years survival after surgery | Study participants will be contacted by study team via phone or e-mail | 3 years | 
| Lidocaine and ropivacaine concentration |  | Intraoperatively | 
| Complication rate after surgery | Resumption of bowel function, anastomotic leakage or hemorrhage | 2 weeks |