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

Glioblastoma Clinical Trial

Official title:
Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04716699
Study type Interventional
Source University of California, Davis
Contact
Status Completed
Phase Phase 1
Start date January 20, 2021
Completion date January 24, 2022
View Details
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