Varied Lidocaine Injection Methods for Pain Management

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Lidocaine allergy, Bleeding disorders, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception. This study is a pilot study designed to determine feasibility of these procedures.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Subjects who are undergoing dermatologic procedures.

Subjects ages 18-89 year old.

The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive injections of lidocaine at varying rates and temperatures to assess pain perception

1 day

1 visit (in-person)

Treatment Part B

Participants receive injections of buffered or non-buffered lidocaine to assess pain perception

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-injection

1 week

Treatment Details

Interventions

• Buffer
• Lidocaine

Trial Overview 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.

Participant Groups

Group I: Slow, Warmed Experimental Treatment 3 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 Temperature Experimental Treatment 3 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, Warmed Experimental Treatment 3 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 Temperature Experimental Treatment 3 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: Buffered Experimental Treatment 3 Interventions

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

Group VI: Non-Buffered Placebo Group 2 Interventions

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

Lidocaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lidocaine for:

• Local anesthesia for minor surgical procedures
• Surface anesthesia for minor procedures
• Spinal anesthesia
• Epidural anesthesia

Approved in European Union as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Surface anesthesia

Approved in Canada as Lidocaine for:

• Local anesthesia
• Regional anesthesia

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+