Lidocaine for Sympathetic Activity in Healthy Subjects

(SPARK Trial)

Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lidocaine, a common local anesthetic, affects nerve activity and blood flow in healthy subjects. Researchers will use ultrasound to guide lidocaine application at the wrist and observe changes in blood vessel function during a cold exposure test. The study examines differences between applying the treatment to the left versus the right wrist. This trial suits healthy individuals without arm injuries or allergies to lidocaine and who can tolerate cold temperatures. As a Phase 4 trial, lidocaine is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What is the safety track record for this treatment?

Research has shown that lidocaine is usually safe for people. It is often used to numb a specific part of the body. Studies have also found that it can help manage some heart conditions by affecting nerve signals.

In past studies, lidocaine lowered blood pressure and slowed the heart rate during medical procedures. These results suggest it can be used safely in those situations. However, very high doses in animal studies showed potential risks to brain areas related to emotions. This highlights the importance of using lidocaine in normal doses for most people.

Since this study is in a later phase, researchers have already carefully reviewed lidocaine's safety. Participants should still consult a doctor to determine if joining the trial is a good choice for them.12345

Why are researchers enthusiastic about this study treatment?

Lidocaine is unique because it acts as a local anesthetic to block nerve signals, potentially reducing sympathetic nervous system activity. Unlike traditional treatments for managing sympathetic activity, which often involve systemic medications like beta-blockers or calcium channel blockers, lidocaine offers a targeted approach through an ultrasound-guided periarterial block. This delivery method at the wrist allows for precise, localized action, which could minimize systemic side effects. Researchers are excited because this could provide a safer, more effective way to manage conditions linked to sympathetic overactivity.

What evidence suggests that lidocaine might be an effective treatment for sympathetic activity?

Research has shown that lidocaine affects the nervous system by lowering the activity of certain nerves, leading to changes in blood pressure and heart rate. Specifically, lidocaine can slow heart rhythms, potentially increasing blood pressure. Additionally, small amounts of lidocaine have been effective in reducing pain and anxiety. This trial will explore lidocaine's effects on nerve activity outside the brain and spinal cord in healthy individuals. Participants will receive either a left or right wrist block using an ultrasound-guided periarterial block with 2% lidocaine.16789

Who Is on the Research Team?

DM

David MacLeod

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50 with no major health issues, who have both hands intact and can follow study instructions. Participants must be able to give informed consent.

Inclusion Criteria

I am between 18 and 50 years old.
* ASA physical status I-II
* Able to comply with study procedures and follow-up
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline measurements of pulse amplitude index and hand temperature are taken before any intervention

1 day
1 visit (in-person)

Intervention

Participants receive an ultrasound-guided periarterial sympathetic block of the distal radial artery

1 day
1 visit (in-person)

Post-Intervention Assessment

Measurements of pulse amplitude index and hand temperature are taken after the sympathetic block and during cold pressor testing

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects or adverse reactions following the intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lidocaine

Trial Overview

Researchers are studying how a lidocaine injection around the radial artery affects nerve activity in the hand. The procedure uses ultrasound guidance and measures changes before and after using special tests.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Right Wrist BlockExperimental Treatment1 Intervention
Group II: Left Wrist BlockExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/1932648/

Lidocaine attenuates efferent sympathetic responses to ...

The effects of antiarrhythmic doses of lidocaine on efferent sympathetic outflow or sympathetic responses to autonomic stimuli in humans are unknown.

Abstract 8302: Lidocaine Abolishes the Sympathetic and ...

In separate studies, 90 mg of lidocaine was added to the saline infusion (n=6). Results- MSNA and mean BP rose towards to the end of infusion in both saline and ...

Influence of lidocaine on human muscle sympathetic nerve ...

Lidocaine appears to reduce sympathetic nerve activity indirectly by slowing ventricular tachycardia cycle length, which results in increased blood pressure ...

Determination of the Duration of Action of a Lidocaine and ...

Our purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a ...

Possible vagal effect of lidocaine: Investigation by HR ...

The administration of lidocaine resulted in an overall increase in mean HR: for the healthy controls an increase of 5.5±2.2%, for the IMJ an increase of 9.4∗3.5 ...

The effects of lidocaine on cardiac parasympathetic control ...

The administration of lidocaine resulted in a significant overall increase in mean heart rate: for the healthy control group an increase of 5.5 ± 2.2% (mean ± ...

Influence of lidocaine on human muscle sympathetic nerve ...

Lidocaine appears to reduce sympathetic nerve activity indirectly by slowing ventricular tachycardia cycle length, which results in increased blood pressure ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/3631561/

Effects of Lidocaine Infusion on the Sympathetic Response ...

It was concluded that the IV infusion of lidocaine during and after major abdominal surgery suppresses extubation-induced hypertension and tachycardia.

Lidocaine for Depressive Symptoms and Comorbid Pain

Animal studies have shown that systemic administration of high-dose lidocaine can induce neurotoxicity in emotion-related brain regions such as the hippocampus ...