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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449289
Recruitment Status : Not yet recruiting
First Posted : June 26, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Theodor Bot, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Intravenous lidocaine Drug: Epidural ropivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024


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 :
  1. 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


Secondary Outcome Measures :
  1. 1- and 3-years survival after surgery [ Time Frame: 3 years ]
    Study participants will be contacted by study team via phone or e-mail

  2. Lidocaine and ropivacaine concentration [ Time Frame: Intraoperatively ]
  3. Complication rate after surgery [ Time Frame: 2 weeks ]
    Resumption of bowel function, anastomotic leakage or hemorrhage



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449289


Contacts
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Contact: Theodor Bot, PhD Student 0040765350176 theo_bot@yahoo.com
Contact: Daniela Ionescu, MD PhD 0744771209 dionescuati@yahoo.com

Locations
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Romania
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
Cluj-Napoca, Romania
Contact: Theodor Bot    0040765350176    theo_bot@yahoo.com   
Sponsors and Collaborators
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Investigators
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Study Director: Daniela Ionescu, MD PhD Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
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Responsible Party: Theodor Bot, PhD student, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
ClinicalTrials.gov Identifier: NCT04449289    
Other Study ID Numbers: 43/3.02.2020
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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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
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Lidocaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action