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Lidocaine for Pain During Syphilis Treatment Injections

This study, called the LIMIT Trial, is looking at whether adding lidocaine (a numbing medicine) to benzathine penicillin G injections can reduce pain for people being treated for syphilis. Syphilis is an infection caused by bacteria called Treponema pallidum. Participants will receive either benzathine penicillin G mixed with lidocaine or benzathine penicillin G mixed with normal saline (saltwater). The main goal is to compare the pain levels experienced 10 minutes after the injection. You can join if you are an adult (18 or older) with a confirmed syphilis diagnosis and are receiving your first injection in a series of treatments. The study aims to enroll 48 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 48 participants to compare pain levels after injections. Participants will receive either benzathine penicillin G with lidocaine or with normal saline.
What's involved
You would receive an injection of benzathine penicillin G mixed with either lidocaine or normal saline. Your pain score would be measured 10 minutes and 24 hours after the injection.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be measured 10 minutes and 24 hours after the injection.

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NCT06391125

LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment

Recruiting
PHASE3Ages 18+InterventionalTreatment
Washington University School of Medicine
~48 participants
Updated 2025-03-25 on ClinicalTrials.gov
What's tested:normal SalineLidocaine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Pain Score (0-10) of Benzathine Penicillin G + Lidocaine Injection 10 minutes post injection
Measured over 10 minutes
+5 more outcomes measured

Conditions

Syphilis Infection
Benzathine Penicillin Adverse Reaction

Explore related trials

Syphilis

Where it's being run

1 sites across 1 states
Missouri1

Who to contact

Joseph Cherabie, MD
[email protected]
7202858096
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults 18 years of age or above
Confirmed syphilis diagnosis (reactive RPR with confirmatory treponemal testing)
Receiving first injection in series if patient requires 3x weekly injections for syphilis treatment

Exclusion

Penicillin allergy (anaphylaxis)
Lidocaine allergy (anaphylaxis)
Second or third injection in series if patient requires 3x weekly injections for syphilis treatment
Pregnancy

What this trial measures

  • Mean Pain Score (0-10) of Benzathine Penicillin G + Lidocaine Injection 10 minutes post injection10 minutes

    The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 10 minutes post injection

  • Mean Pain Score (0-10) of Benzathine Penicillin G + Saline Injection 10 minutes post injection10 minutes

    The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 10 minutes post injection

  • Relative difference of mean pain scores between injection types 10 minutes post injection10 minutes

    Comparative t-test of means of pain scores at injections sites at 10 minutes post injection

  • Mean Pain Score (0-10) of Benzathine Penicillin G + Lidocaine Injection 24 hours post injection24 hours

    The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 24 hourspost injection

  • Mean Pain Score (0-10) of Benzathine Penicillin G + Saline Injection 24 hours post injection24 hours

    The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 24 hours post injection

  • Relative difference of mean pain scores between injection types at 24 hours post injection24 hours

    Comparative t-test of means of pain scores at injections sites at 24 hours post injection