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

• Status: Recruiting
• Trial end date: 2023-01-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kiarash Shahlaie, M.D., Ph.D.
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• >= 18 years of age

• Preoperative imaging characteristics consistent with brain glioblastoma (magnetic resonance imaging [MRI] brain)

• Patients who are undergoing neurosurgical resection for treatment of glioblastoma

• Ability to understand and willingness to sign an informed consent form

• Ability to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

• Prior treatment for glioblastoma

• Glioblastoma size less than 5 cm^3

• Known allergy against amide type of local anesthetics

• History of severe cardiac failure (determined by clinical history of less the 3 Metabolic Equivalent of Tasks [METs])

• 2nd or 3rd degree heart block (exception: patients with pacemaker)

• Concurrent treatment with class I or III antiarrhythmics (phenytoin, procainamide, propranolol, quinidine) or amiodarone use =< 3 months

• History of Wolff-Parkinson-White syndrome, Stokes Adams syndrome, or active dysrhythmia

• History of bradycardia

• Prior clinical history of severe hepatic impairment or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.55 times of upper normal limit

• Prior clinical history of severe renal impairment or estimated glomerular filtration rate (EGFR) < 30ml/min

• Uncontrolled seizure disorder

• Acute porphyria

• Patients requiring an awake fiberoptic intubation due to administration of additional lidocaine

• Pregnant or lactating women

• Any condition that would prohibit the understanding or rendering of informed consent

• Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that in the opinion of the investigator would prevent the subject from participating and adhering to study related procedures

• Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient's safety or compliance on trial