Lidocaine Infusion in Pancreatic Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT04048278
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine Hydrochloride — DRUG
    IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
  • Saline Solution for Injection — DRUG
    IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Study Details

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.

Key Dates

Start date
Nov 8, 2018
Status verified
Nov 2024
Primary completion
Nov 8, 2025
Completion
Jan 1, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

Specimen outcome measure. [ Time Frame: Outcomes will be evaluated perioperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illnois at ChicagoChicagoIllinois60612
Gina E Votta-Velis, MD PhD
[email protected]
(312)996-4020
Alexandra Barabanova, MS
[email protected]
(312)355-5733
E. Gina Votta-Velis, MD PhD (PRINCIPAL_INVESTIGATOR)
Ajay Rana, PhD (SUB_INVESTIGATOR)
Pier C. Giulianotti, MD (SUB_INVESTIGATOR)
Alain A. Borgeat, MD (SUB_INVESTIGATOR)
Sandeep Kumar, PhD (SUB_INVESTIGATOR)
Antonio Gangemi, MD (SUB_INVESTIGATOR)
Valentina Valle, MD (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Illnois at Chicago· Chicago, IL

Related Studies