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

NCT04449289 | Unknown Phase 2

• 1 other identifier: 43/3.02.2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 1- and 3-years recurrence rate after surgery

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

  3 years

Secondary Outcomes (3)

• 1- and 3-years survival after surgery

  3 years

• Lidocaine and ropivacaine concentration

  Intraoperatively

• Complication rate after surgery

  2 weeks

Study Arms (2)

Intravenous lidocaine

ACTIVE COMPARATOR

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

Drug: Intravenous lidocaine

Epidural ropivacaine

ACTIVE COMPARATOR

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

Drug: Epidural ropivacaine

Interventions

Intravenous lidocaine DRUG

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

Intravenous lidocaine

Epidural ropivacaine DRUG

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

Epidural ropivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor: lead

Study Sites (1)

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

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Daniela Ionescu, MD PhD

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

  STUDY DIRECTOR

Central Study Contacts

Theodor Bot, PhD Student

CONTACT

0040765350176; theo_bot@yahoo.com

Daniela Ionescu, MD PhD

CONTACT

0744771209; dionescuati@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 26, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2024
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

RO (1)