NCT04048278

Lidocaine Infusion in Pancreatic Cancer

Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

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

Timeline

• Start date: 2018-11-08
• Primary completion: 2025-11-08
• Completion: 2026-01-01
• First posted: 2019-08-07
• Last updated: 2025-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study