Pancreatic Cancer
Conditions
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.
Interventions
Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia
Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia
Sponsors
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1- and 3-years recurrence rate after surgery | 3 years | Study participants will be contacted by study team via phone or e-mail |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Complication rate after surgery | 2 weeks | Resumption of bowel function, anastomotic leakage or hemorrhage |
Countries
Romania
Contacts
Primary ContactTheodor Bot, PhD Student
Backup ContactDaniela Ionescu, MD PhD
Outcome results
None listed