Recruiting
Early Phase 1

Lidocaine

Sponsor:

University of Illinois at Chicago

Code:

NCT04048278

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine Hydrochloride

Saline Solution for Injection

Study Details

Brief summary:

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.

Conditions

Pancreatic Cancer

Study ID

NCT04048278

Start date

Nov 8, 2018

Status verified date

Jun, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Nov 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h

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)

Interventions

Lidocaine Hydrochloride

IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Saline Solution for Injection

IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Primary outcome measure

  • Specimen outcome measure. [ Time Frame: Outcomes will be evaluated perioperatively ]
  • Specimen outcome measure. [ Time Frame: Outcomes will be evaluated perioperatively ]
  • Specimen outcome measure. [ Time Frame: Outcomes will be evaluated perioperatively ]
  • Upregulation or Downregulation of Gene Expression. [ Time Frame: Outcomes will be evaluated perioperatively ]

Central Contacts and Locations

Central contacts

Alexandra Barabanova, MS

(312)996-4020barabano@uic.edu

Gina E. Votta-Velis, MD PhD

(312)996-4020barabano@uic.edu

Locations

University of Illnois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Gina E Votta-Velis, MD PhD

(312)996-4020ginavot@uic.edu

Alexandra Barabanova, MS

(312)355-5733barabano@uic.edu

Principal Investigator:

E. Gina Votta-Velis, MD PhD

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Pancreas
  • Pancreatic Cancer
  • Lidocaine
  • Enzymatic Activity
  • Cytokines
  • Chemokines
  • Gene Expression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-06-15.