Influence Of Local Anesthetic Administration On The Cancer Recurrence Rate After Pancreatic Oncologic Surgery

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Intravenous lidocaine
DRUG: Epidural ropivacaine

43/3.02.2020

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-06-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-06-24
First Submitted that Met QC Criteria 2020-06-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-06-26
First Posted (ACTUAL) 2020-06-26	Results First Posted N/A	Last Verified 2020-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Intravenous lidocaine Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative	DRUG: Intravenous lidocaine Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia
ACTIVE_COMPARATOR: Epidural ropivacaine Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively	DRUG: Epidural ropivacaine Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Intravenous lidocaine

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

DRUG: Intravenous lidocaine

Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia

ACTIVE_COMPARATOR: Epidural ropivacaine

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

DRUG: Epidural ropivacaine

Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Theodor Bot, PhD Student

Phone Number: 0040765350176

Email: theo_bot@yahoo.com

Study Contact Backup

Name: Daniela Ionescu, MD PhD

Phone Number: 0744771209

Email: dionescuati@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

diagnosis of pancreatic cancer
American Society of Anesthesiologists (ASA) risk I - III

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Daniela Ionescu, MD PhD, Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record