Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2022-11-22
2023-11-17
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Lidocaine
Subjects will receive lidocaine during the drug portion of the experiment.
Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using an electric nerve stimulator.
Lidocaine IV
Subjects will receive an intravenous infusion of lidocaine for about 30 minutes.
Interventions
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Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using an electric nerve stimulator.
Lidocaine IV
Subjects will receive an intravenous infusion of lidocaine for about 30 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be of normal body-weight
* Be generally healthy
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Keith M Vogt
OTHER
Responsible Party
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Keith M Vogt
Associate Professor of Anesthesiology & Perioperative Medicine
Principal Investigators
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Keith M Vogt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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Vogt KM, Burlew AC, Simmons MA, Reddy SN, Kozdron CN, Ibinson JW. Neural correlates of systemic lidocaine administration in healthy adults measured by functional MRI: a single arm open label study. Br J Anaesth. 2025 Feb;134(2):414-424. doi: 10.1016/j.bja.2024.07.039. Epub 2024 Oct 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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STUDY21120115
Identifier Type: -
Identifier Source: org_study_id