NCT04716699

Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma

Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial measures the amount and effect of lidocaine injected into patients with glioblastoma while they are undergoing surgical removal of their brain tumors. Lidocaine is a substance used to relieve pain by blocking signals at the nerve endings in skin. Information gained from this study may help researchers come up with new treatments to help patients with glioblastomas in the future.

Detailed description

PRIMARY OBJECTIVE: I. To assess the pharmacokinetic properties of intravenously administered lidocaine inside a glioblastoma tumor by means of mass spectroscopy. SECONDARY OBJECTIVE: I. To assess the differences in overall survival (OS) and progression free survival (PFS) between the patients in the lidocaine therapy group and historical controls taken from the literature (Stupp et al) with comparable post-operative treatment regimen. OUTLINE: Patients receive bolus lidocaine intravenously (IV) per standard of care. After intubation, patients receive another infusion of lidocaine IV over 4 hours or until the end of surgery. Patients also undergo collection of blood and tumor samples at the start of surgery and hourly afterwards until a total of 4 samples are collected. After completion of surgery, patients are followed for 24 hours, and at 7-14 days, up to 30 days.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood and tumor samples
DRUG	Lidocaine	Given IV
PROCEDURE	Resection	Undergo surgical resection per standard of care

Timeline

• Start date: 2021-01-20
• Primary completion: 2021-12-26
• Completion: 2022-01-24
• First posted: 2021-01-20
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study