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

NCT ID: NCT04449289

Last Updated: 2020-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous lidocaine

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

Group Type ACTIVE_COMPARATOR

Intravenous lidocaine

Intervention Type DRUG

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

Epidural ropivacaine

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

Group Type ACTIVE_COMPARATOR

Epidural ropivacaine

Intervention Type DRUG

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

Interventions

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Intravenous lidocaine

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

Intervention Type DRUG

Epidural ropivacaine

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Theodor Bot

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela Ionescu, MD PhD

Role: STUDY_DIRECTOR

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

Locations

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

Cluj-Napoca, , Romania

Site Status

Countries

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Romania

Central Contacts

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Theodor Bot, PhD Student

Role: CONTACT

0040765350176

Daniela Ionescu, MD PhD

Role: CONTACT

0744771209

Facility Contacts

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Theodor Bot

Role: primary

0040765350176

Other Identifiers

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43/3.02.2020

Identifier Type: -

Identifier Source: org_study_id

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