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

Phase 3

Not yet recruiting

• Conditions: Benzathine Penicillin Adverse Reaction; Syphilis Infection
• Interventions: Drug: normal Saline; Drug: Lidocaine

• Registration Number: NCT06391125
• Lead Sponsor: Washington University School of Medicine

Brief Summary

There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G (BPG) or Bicillin, used to treat syphilis infections. A study published in the Journal of Family Practice in 2001 compared the pain experienced during bicillin injections with and without the use of lidocaine. The study fou...

Detailed Description

The purpose of the study is to test the question of: Does the addition of 0.5ml 1% lidocaine compared to 0.5 ml normal saline solution to 1.2 million units of benzathine penicillin G affect the pain experienced by individuals being treated for Treponema pallidum (syphilis) infections at 10 minutes and 24 hours post injection?

Background
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Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-04-27
• Study First Posted: 2024-04-30
• Status Verified: 2024-07
• Study Start: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal Saline + Benzthine Penicillin G Arm	normal Saline	0.5ml normal saline solution added to prefilled 1.2 million units Benzathine Pencillin G syringe which will be injected once into the gluteal muscle of the study participant, the side (left or right) to be randomly assigned with the study arm assigned to the other gluteal muscle.
Lidocaine + Benzathine Penicillin G Arm	Lidocaine	0.5ml 1% lidocaine solution added to prefilled 1.2 million units Benzathine Pencillin G syringe which will be injected once into the gluteal muscle of the study participant, the side (left or right) to be randomly assigned with the control assigned to the other gluteal muscle.

Primary Outcome Measures

Name	Time	Method
Mean Pain Score (0-10) of Benzathine Penicillin G + Saline Injection 10 minutes post injection	10 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 24 hours post injection	24 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 10 minutes post injection	10 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 injection	24 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 + Lidocaine Injection 10 minutes post injection	10 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 at 24 hours post injection	24 hours	Comparative t-test of means of pain scores at injections sites at 24 hours post injection

Secondary Outcome Measures

Name	Time	Method
Rate of Adverse reactions	7 days	To see if there are any adverse effects of adding 0.5 ml 1% lidocaine to prepackaged Benzathine Penicillin G
Rate of Use of other pain medications	24 hours	To assess use of other pain medications 24 hours post injection.