Phase 1
N=30
Neural Correlates of Lidocaine Analgesia
Anesthesia · Pain
Bottom Line
View on ClinicalTrials.gov: NCT05501600 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition — 3.6 Z-score — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Peripheral Nerve Stimulation (Device); Lidocaine IV (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Keith M Vogt
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition |
3.6 | 0.004 sig |
| PRIMARY Resting-state Functional Connectivity Difference: Drug-free Minus Lidocaine |
3.25 | 0.081616 |
| SECONDARY Pain Intensity Score Difference, Drug-free Condition Minus Lidocaine Condition |
0.4 | — |
| SECONDARY Memory Performance Difference, Drug-free Minus Lidocaine Condition |
0.48 | — |
| SECONDARY Motor Response Time Differences |
10 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
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
Data sourced from ClinicalTrials.gov (NCT05501600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.