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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Apr 27, 2024

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Syphilis Syphilis Treatment Benzathine Penicillin G Lidocaine

ClinConnect Summary

The LIMIT Trial is studying whether adding lidocaine, a local anesthetic that numbs the area, can help reduce pain from injections of benzathine penicillin G (BPG), which is used to treat syphilis. Past studies have shown that lidocaine can lessen the discomfort of these injections, but this trial aims to confirm those findings in a more controlled way. Participants will receive two injections of BPG: one will have lidocaine added to it, while the other will not, and neither the participants nor the healthcare providers will know which injection contains lidocaine and which has a saltwater solution instead.

To be eligible for this trial, participants must be adults aged 18 or older with a confirmed syphilis diagnosis and be receiving their first injection in a series. Those with allergies to penicillin or lidocaine, or who are pregnant, cannot participate. After the injections, participants will report their pain levels at two different times, helping researchers understand if lidocaine truly makes a difference in reducing pain during BPG injections. This study is an important step in improving the treatment experience for patients receiving these necessary injections.

Gender

ALL

Eligibility 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

About Washington University School Of Medicine

Washington University School of Medicine is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research, education, and patient care. With a strong emphasis on translating scientific discoveries into practical applications, the institution conducts a diverse array of clinical trials aimed at improving treatment outcomes and enhancing the understanding of various medical conditions. Its collaborative environment fosters partnerships between researchers, clinicians, and community stakeholders, ensuring that the trials not only contribute to scientific knowledge but also address the pressing health needs of diverse populations.

Locations

Saint Louis, Missouri, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported