Varied Lidocaine Injection Methods for Pain Management

N/A

Waitlist Available

Led By Murad Alam, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Summary

This trial will collect data from multiple academic institutions to study the effect of anesthetic injection rate and temperature on pain perception during dermatologic procedures, as well as if buffering the anesthetic solution alters pain perception.

Who is the study for?

This trial is for individuals aged 18-89 who are about to undergo dermatologic procedures and can understand and agree to the study's terms. It's not suitable for those who don't meet these age requirements or cannot give informed consent.

What is being tested?

The study tests how pain perception changes with different lidocaine injections during skin procedures. Part A examines the effect of injection speed and temperature, while Part B looks at whether adding a buffer to the anesthetic alters pain levels.

What are the potential side effects?

Potential side effects may include discomfort or pain at the injection site, possible bruising or bleeding, allergic reactions to lidocaine, or temporary numbness in the area treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain on a Visual Analog Scale (VAS)

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Slow, WarmedExperimental Treatment3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group II: Slow, Room TemperatureExperimental Treatment3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group III: Rapid, WarmedExperimental Treatment3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group IV: Rapid, Room TemperatureExperimental Treatment3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group V: BufferedExperimental Treatment3 Interventions

In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.

Group VI: Non-BufferedPlacebo Group2 Interventions

In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine

2011

Completed Phase 4

~1370