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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

Tracking Information
First Submitted Date  ICMJE June 24, 2020
First Posted Date  ICMJE June 26, 2020
Last Update Posted Date June 26, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • 1- and 3-years survival after surgery [ Time Frame: 3 years ]
    Study participants will be contacted by study team via phone or e-mail
  • Lidocaine and ropivacaine concentration [ Time Frame: Intraoperatively ]
  • Complication rate after surgery [ Time Frame: 2 weeks ]
    Resumption of bowel function, anastomotic leakage or hemorrhage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
Official Title  ICMJE Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Intravenous lidocaine
    Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia
  • Drug: Epidural ropivacaine
    Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia
Study Arms  ICMJE
  • Active Comparator: Intravenous lidocaine
    Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative
    Intervention: Drug: Intravenous lidocaine
  • Active Comparator: Epidural ropivacaine
    Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively
    Intervention: Drug: Epidural ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Theodor Bot, PhD Student 0040765350176 theo_bot@yahoo.com
Contact: Daniela Ionescu, MD PhD 0744771209 dionescuati@yahoo.com
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04449289
Other Study ID Numbers  ICMJE 43/3.02.2020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theodor Bot, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Study Sponsor  ICMJE Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniela Ionescu, MD PhD Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
PRS Account Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP