$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Lidocaine Infusion in Pancreatic Cancer

2018-11-08

2025-11-08

2026-01-01

46

Study Overview

Lidocaine Infusion in Pancreatic Cancer

This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer. A prospective randomized controlled double blinded trial design will be used for the proposed study.

The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is expected that by downregulating the pathways by lidocaine might affect the enzymatic activity in those CTCs as well as the number of CTCs in the circulation. A prospective randomized controlled double blinded trial design will be used for the proposed study. Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.

  • Pancreatic Cancer
  • DRUG: Lidocaine Hydrochloride
  • DRUG: Saline Solution for Injection
  • 2017-1365

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-06-18  

N/A  

2025-02-26  

2019-08-06  

N/A  

2025-03-03  

2019-08-07  

N/A  

2024-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Lidocaine Hydrochloride

The IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loa

DRUG: Lidocaine Hydrochloride

  • IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
PLACEBO_COMPARATOR: Saline Solution for Injection

The group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr)

DRUG: Saline Solution for Injection

  • IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Primary Outcome MeasuresMeasure DescriptionTime Frame
Specimen outcome measure.Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.Outcomes will be evaluated perioperatively
Specimen outcome measure.Cytokine Levels in Serum (pg/ml)Outcomes will be evaluated perioperatively
Specimen outcome measure.Chemokine levels in serum (pg/ml)Outcomes will be evaluated perioperatively
Upregulation or Downregulation of Gene Expression.Upregulation or downregulation of gene expression will be measured with the Real Time (RT) square Profiler Polimerase Chain Reaction (PCR )Array Analysis, and Real Time PCROutcomes will be evaluated perioperatively
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Specimen outcome measureCTCs EnumerationPerioperatively

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Alexandra Barabanova, MS

Phone Number: (312)996-4020

Email: barabano@uic.edu

Study Contact Backup

Name: Gina E. Votta-Velis, MD PhD

Phone Number: (312)996-4020

Email: barabano@uic.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is considered resectable as well as other types of pancreatic cancer (malignant endocrine and exocrine tumors) 2. Has measurable disease, defined as at least 1 tumor that fulfills the criteria 3. Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease 4. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC) 5. Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
    Exclusion Criteria:
    1. Has American Society of Anesthesiologists (ASA) physical status > 3 2. Has hypersensitivity or allergy to amide-linked local anesthetics 3. Has a second or third degree heart block 4. Has severe sinoatrial block 5. Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide 6. Has been treated with amiodarone in the past 7. Has Adams-Stoke syndrome 8. Has Wolff-Parkinson-White syndrome 9. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment 10. Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Gina E. Votta-Velis, MD PhD, Associate Professor

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.
    • Mokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195. doi: 10.1053/ejso.1999.0771. No abstract available.
    • Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.
    • Han L, Chen W, Zhao Q. Prognostic value of circulating tumor cells in patients with pancreatic cancer: a meta-analysis. Tumour Biol. 2014 Mar;35(3):2473-80. doi: 10.1007/s13277-013-1327-5. Epub 2013 Nov 12.
    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate