Using lidocaine to reduce pain from benzathine penicillin injections for syphilis treatment
Official title: LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
Run by Washington University School of Medicine · NCT06391125 · Data updated 2026-11-12
This study is testing if adding lidocaine to syphilis treatment injections can help reduce the pain patients feel during and after the shot.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | March 25, 2025 |
| Trial ID | NCT06391125 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of syphilis who are receiving their first injection in a treatment series.
✕Probably not a fit
Patients with allergies to penicillin or lidocaine, or those who are pregnant, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate whether the addition of lidocaine to benzathine penicillin G injections can reduce the pain experienced by patients being treated for syphilis infections. Participants will receive either benzathine penicillin G with lidocaine or with normal saline, and their pain levels will be assessed at 10 minutes and 24 hours post-injection. The study is designed as a randomized controlled trial to provide robust evidence on the efficacy of lidocaine in this context. The trial is particularly relevant given the challenges of using lidocaine as a diluent in the US compared to European practices.
Why it matters
Potential benefit: If successful, this approach could significantly improve the comfort of patients receiving treatment for syphilis.
How similar studies have gone: Previous studies have shown that lidocaine can effectively reduce injection pain, suggesting a positive outlook for this trial's approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Penicillin allergy (anaphylaxis) * Lidocaine allergy (anaphylaxis) * Second or third injection in series if patient requires 3x weekly injections for syphilis treatment * Pregnancy
Where it's running
-
WashU Infectious Diseases Clinic
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Joseph Cherabie, MD
- Email: jcherabie@wustl.edu
- Phone: 7202858096
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.