Neural Correlates of Lidocaine Analgesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition
研究概览
简要总结
The purpose of this study is to characterize the effects of intravenous lidocaine on pain processing and cognitive function. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will consist of 1 visit and involves no long-term follow up.
详细描述
This is an observational cohort study of volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of intravenous lidocaine on pain processing and cognitive function. A steady-state effect-site concentration of lidocaine will be achieved, and a short battery of cognitive behavioral tasks will be employed. At the dose target, pain task functional MRI and resting-state connectivity will be determined. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of intravenous lidocaine, a commonly-used opioid alternative analgesic agent.
Aim1: Determine cognitive behavioral effects of a steady-state dose of IV lidocaine using a short battery of tasks. The investigators hypothesize that the administration of lidocaine will correlate to decreased pain ratings, slowed psychomotor response, and decreased memory encoding.
Aim2: Determine the neural effects of a steady-state dose of IV lidocaine in response to acute pain, and on resting connectivity. The investigators hypothesize that pain task-related activation will decrease in the insula and anterior cingulate, corresponding to decreased ratings of pain intensity and unpleasantness. Additionally, the investigators expect widespread decreases in long-range functional connectivity between brain areas know to be involved in these two areas and other known to be involved in pain processing.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 70
- •Be of normal body-weight
- •Be generally healthy
- •Have none of the specific exclusion criteria
- •Have a valid email address and phone number throughout the study
排除标准
- •Pregnancy
- •Body mass index > 40
- •Having moderate to severe sleep apnea
- •Having chronic pain requiring the regular use of pain medicine 3 or more times per week
- •Having neurologic or psychiatric disease, including benign tremor, anxiety, and depression
- •Having a history of seizures
- •Having history of cardiac rhythm disturbance (such as heart block, or atrial fibrillation)
- •Being severely claustrophobic
- •Having metal implants or non-removable metal piercings
- •Having metal-containing tattoos, particularly on the face
- •Having a history of adverse reaction to lidocaine
- •Are regularly taking: antiepileptics, antidepressants, anti-psychotics, anti-anxiety medication, stimulants, sleep-aids, or pain medication
- •Are taking prescribed medications for psychiatric or neurological conditions
- •Having hypersensitivity to lidocaine or to any other local anesthetics of the amide type
- •Having Wolff-Parkinson-White syndrome
- •Having known renal or hepatic dysfunction
- •having glucose-6-phosphate dehydrogenase deficiency or history of methemoglobinemia
研究组 & 干预措施
Lidocaine
Subjects will receive lidocaine during the drug portion of the experiment.
干预措施: Peripheral Nerve Stimulation (Device)
Lidocaine
Subjects will receive lidocaine during the drug portion of the experiment.
干预措施: Lidocaine IV (Drug)
结局指标
主要结局
Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition
时间窗: 4.5 minutes
The Z-score is calculated by linear regression of the task timing against the MRI signal time-course (MRI data is in arbitrary units with no maximum or minimum) at each voxel (single data point in brain). Primary outcome is listed for the Right insula, but similar scores are calculated throughout the brain. Z-score of 0 indicates no task-related changes. Z-scores further from zero indicate stronger correlation between functional MRI signal change and the task timing, with positive values indicating increases in fMRI signal and negative Z-scores indicating decreases. Practically, higher positive Z-scores indicate increased brain activity and larger negative Z-scores indicate decreased brain activity. This outcome is reported as a number, as it is calculated using all the data across subjects combined into one statistical measure for the overall strength of difference in MRI signal change between two groups of data. Dispersion measures cannot be calculated for the summary Z-score.
Resting-state Functional Connectivity Difference: Drug-free Minus Lidocaine
时间窗: 8 minutes
Functional connectivity (FC) measures the correlation of MRI signal time-series between brain regions. Changes in FC reflect differences in brain state, in this case between drug-free and lidocaine conditions. The reported value is the FC change between the right insula and anterior cingulate. A T-statistic of 0 indicates no change; more positive scores mean stronger connectivity in the drug-free condition, and more negative scores mean stronger connectivity with lidocaine. This outcome is a number reflecting the overall magnitude of difference between two datasets, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
次要结局
- Pain Intensity Score Difference, Drug-free Condition Minus Lidocaine Condition(12 minutes)
- Memory Performance Difference, Drug-free Minus Lidocaine Condition(3 minutes)
- Motor Response Time Differences(1 minute)
研究者
Keith M Vogt
Associate Professor of Anesthesiology & Perioperative Medicine
University of Pittsburgh