Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 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
排除标准
- •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
研究组 & 干预措施
Health services research (lidocaine, surgery)
Patients receive bolus lidocaine 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.
干预措施: Biospecimen Collection (Procedure)
Health services research (lidocaine, surgery)
Patients receive bolus lidocaine 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.
干预措施: Lidocaine (Drug)
Health services research (lidocaine, surgery)
Patients receive bolus lidocaine 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.
干预措施: Resection (Procedure)
结局指标
主要结局
Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
时间窗: At start of surgery up until completion of surgery, assessed up to 4 hours after starting surgery
Analysis is mainly descriptive and will be mainly done by Lidocaine analysis lab. Will report the mean and standard deviation of concentration of lidocaine in the tumor and blood at 3 time points. The pharmacokinetics of lidocaine within the tumor will be summarized using the means, and standard pharmacokinetics parameters will be reported (maximum concentration, time of maximum concentration, and area under the curve). If applicable, will use mixed effects model to summarize trajectories of change for concentration measured at multiple time points, which will account for correlation between repeated measures within patient.
次要结局
- Progression free survival (PFS)(From diagnosis to first documented evidence of disease progression or death, whichever comes first, assessed up to 30 days after surgery)
- Overall survival (OS)(From diagnosis to death, assessed up to 30 days after surgery)
- Incidence of adverse events (AEs)(Up to 30 says after surgery)
研究者
Kiarash Shahlaie, M.D., Ph.D.
Principal Investigator
University of California, Davis