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

Primary Purpose

Pancreatic Cancer

Status

Not yet recruiting

Phase

Phase 2

Locations

Romania

Study Type

Interventional

Intervention

Intravenous lidocaine

Epidural ropivacaine

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intravenous lidocaine

Epidural ropivacaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

1- and 3-years recurrence rate after surgery

Study participants will be contacted by study team via phone or e-mail

Secondary Outcome Measures

1- and 3-years survival after surgery

Study participants will be contacted by study team via phone or e-mail

Lidocaine and ropivacaine concentration

Complication rate after surgery

Resumption of bowel function, anastomotic leakage or hemorrhage

Full Information

NCT ID

NCT04449289

First Posted

June 24, 2020

Last Updated

June 24, 2020

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT04449289

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2020 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous lidocaine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Epidural ropivacaine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intravenous lidocaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Epidural ropivacaine

Intervention Description

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

Primary Outcome Measure Information:

Title

1- and 3-years recurrence rate after surgery

Description

Study participants will be contacted by study team via phone or e-mail

Time Frame

3 years

Secondary Outcome Measure Information:

Title

1- and 3-years survival after surgery

Description

Study participants will be contacted by study team via phone or e-mail

Time Frame

3 years

Title

Lidocaine and ropivacaine concentration

Time Frame

Intraoperatively

Title

Complication rate after surgery

Description

Resumption of bowel function, anastomotic leakage or hemorrhage

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Theodor Bot, PhD Student

Phone

0040765350176

theo_bot@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Daniela Ionescu, MD PhD

Phone

0744771209

dionescuati@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniela Ionescu, MD PhD

Organizational Affiliation

Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor

Official's Role

Study Director

Facility Information:

Facility Name

Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"

City

Cluj-Napoca

Country

Romania

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Theodor Bot

Phone

0040765350176

theo_bot@yahoo.com

12. IPD Sharing Statement

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

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