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

June 24, 2020 updated by: Theodor Bot, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

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

Study Contact Backup

Study Locations

  • Romania
      • Cluj-Napoca, Romania
        • Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

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

Investigators

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

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 Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (ACTUAL)

June 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43/3.02.2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Intravenous lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe