Lidocaine Blocks for Regional Anesthesia (DEVILS Trial)

Durham, NC

Phase 4

Waitlist Available

Led By Brian Mendelson, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASA physical status 1 or 2

Age ≥ 18 years

Must not have

Systemic neuromuscular disease

Contraindications to regional anesthesia (e.g., infection, allergy, challenging sonoanatomy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up basiline, 10, 20, 30, 45, 60, 90, 120 and 240 minutes post block.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to compare two nerve block techniques, the Erector Spinae Plane (ESP) block and the Intertransverse Process (ITP) block, in terms of their effectiveness in providing

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Who is the study for?

This trial is for healthy adult volunteers interested in helping compare two regional anesthesia techniques for chest wall pain relief. Participants should be available for two separate procedure days and willing to undergo sensory testing and blood draws.Check my eligibility

What is being tested?

The study tests the distribution of numbness caused by two nerve block techniques, ESP and ITP, using Lidocaine. It also examines how Lidocaine is absorbed into the body with each technique. Volunteers will receive both blocks on different days.See study design

What are the potential side effects?

Potential side effects include typical reactions to local anesthetics like Lidocaine, which may involve temporary numbness or tingling at the injection site, lightheadedness, or rarely more serious effects if absorbed systemically.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in good or mild systemic disease condition.

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I am 18 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a disease that affects my muscles and nerves.

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I cannot have regional anesthesia due to an infection, allergy, or other issues.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ basiline, 10, 20, 30, 45, 60, 90, 120 and 240 minutes post block.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~basiline, 10, 20, 30, 45, 60, 90, 120 and 240 minutes post block.

This trial's timeline: 3 weeks for screening, Varies for treatment, and basiline, 10, 20, 30, 45, 60, 90, 120 and 240 minutes post block. for reporting.