Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391125
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-20
Brief Title:
LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIMIT
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 found that patients who received lidocaine injections before receiving bicillin reported significantly less pain compared to those who received bicillin injections without lidocaine Per the International Union against Sexually Transmitted Infections IUSTI European Guidelines for syphilis management lidocaine has been used as a diluent for BPG since 1998 In the United States US BPG often comes prepackaged and lidocaine is unable to be used as a diluent with the same ease as it is in Europe In light of this the investigators propose a randomized controlled trial of benzathine penicillin G with and without lidocaine to quantify any site pain reduction with lidocaine in patients being treated for syphilis
This study is a randomized double blinded placebo controlled trial During this study patients needing BPG treatment for syphilis will be screened for any penicillin allergies and consented to their participation Each participant will receive 2 injections of BPG 12 million units each 2x12 million units 24 million units the standard dose for syphilis treatment as intramuscular injections one in each gluteal muscle with one of the injections randomly having 05ml of 1 lidocaine added while the other has 05 ml normal saline solution The side of each injection will be randomized by the medical assistant MAnurse filling the vials and the injecting MA will be blinded as well as the study participant as to which vial contains lidocaine and which contains normal saline The participants will then be asked to rate their pain from 0-10 on each site of injection at 10 minutes post injection then again at 24 hours after injection via email electronic survey via RedCap The differences in pain from the two injections will be compared and analyzed to see if lidocaine reduces pain associated with BPG injections compared to the control of normal saline added to BPG
This study is a randomized double blinded placebo controlled trial During this study patients needing BPG treatment for syphilis will be screened for any penicillin allergies and consented to their participation Each participant will receive 2 injections of BPG 12 million units each 2x12 million units 24 million units the standard dose for syphilis treatment as intramuscular injections one in each gluteal muscle with one of the injections randomly having 05ml of 1 lidocaine added while the other has 05 ml normal saline solution The side of each injection will be randomized by the medical assistant MAnurse filling the vials and the injecting MA will be blinded as well as the study participant as to which vial contains lidocaine and which contains normal saline The participants will then be asked to rate their pain from 0-10 on each site of injection at 10 minutes post injection then again at 24 hours after injection via email electronic survey via RedCap The differences in pain from the two injections will be compared and analyzed to see if lidocaine reduces pain associated with BPG injections compared to the control of normal saline added to BPG
Detailed Description:
The purpose of the study is to test the question of Does the addition of 05ml 1 lidocaine compared to 05 ml normal saline solution to 12 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
Prior Literature and Studies and Rationale for this Study
There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G or bicillin used to treat syphilis infections A study published in the Journal of Pediatric Infectious Diseases in 1998 found that the use of lidocaine as a diluent of BPG significantly reduced the pain of injection Another study by Estrada et al in 2019 looked at the addition of 1 mepivicaine as diluent for PGB vs PGB alone and showed that mepivicaine significantly decreased pain experienced by participants Per the IUSTI European Guidelines for Syphilis management lidocaine is used as a diluent for benzathine penicillin G since 1998 No studies have been performed thus far looking at prefilled benzathine penicillin G syringes and the possibility of inserting lidocaine to the injection to decrease the pain experienced by individuals being treated for syphilis infections instead of using lidocaine as a diluent which is not possible for the BPG formulations present here in the US
Study Objectives
Primary Aim To see if there is any benefit of adding 05 ml 1 lidocaine to prepackaged Benzathine Penicillin G with respect to pain compared to standard of care in the treatment of Treponema pallidum infections both 10 minutes and 24 hours after injection
Secondary Aim To see if there are any adverse effects of adding 05 ml 1 lidocaine to prepackaged Benzathine Penicillin G and to assess use of other pain medications 24 hours post injection
Dose Rationale and RiskBenefits Use of 05 ml 1 lidocaine was decided upon based off the size of the prefilled BPG syringe and the room for additional liquid within the syringe 1 lidocaine is commonly used as a pain relief measure in clinical settings for injections and other procedures
Overview or Design Summary This study is a double blinded randomized placebo control trial of addition of the effect on pain of the addition of 05ml 1 lidocaine solution to prepackaged benzathine Penicillin G injection compared to addition of 05 ml normal saline solution in adults being treated for syphilis Treponema pallidum infections within the Infectious Diseases Clinic at Washington University in St Louis
Background
Prior Literature and Studies and Rationale for this Study
There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G or bicillin used to treat syphilis infections A study published in the Journal of Pediatric Infectious Diseases in 1998 found that the use of lidocaine as a diluent of BPG significantly reduced the pain of injection Another study by Estrada et al in 2019 looked at the addition of 1 mepivicaine as diluent for PGB vs PGB alone and showed that mepivicaine significantly decreased pain experienced by participants Per the IUSTI European Guidelines for Syphilis management lidocaine is used as a diluent for benzathine penicillin G since 1998 No studies have been performed thus far looking at prefilled benzathine penicillin G syringes and the possibility of inserting lidocaine to the injection to decrease the pain experienced by individuals being treated for syphilis infections instead of using lidocaine as a diluent which is not possible for the BPG formulations present here in the US
Study Objectives
Primary Aim To see if there is any benefit of adding 05 ml 1 lidocaine to prepackaged Benzathine Penicillin G with respect to pain compared to standard of care in the treatment of Treponema pallidum infections both 10 minutes and 24 hours after injection
Secondary Aim To see if there are any adverse effects of adding 05 ml 1 lidocaine to prepackaged Benzathine Penicillin G and to assess use of other pain medications 24 hours post injection
Dose Rationale and RiskBenefits Use of 05 ml 1 lidocaine was decided upon based off the size of the prefilled BPG syringe and the room for additional liquid within the syringe 1 lidocaine is commonly used as a pain relief measure in clinical settings for injections and other procedures
Overview or Design Summary This study is a double blinded randomized placebo control trial of addition of the effect on pain of the addition of 05ml 1 lidocaine solution to prepackaged benzathine Penicillin G injection compared to addition of 05 ml normal saline solution in adults being treated for syphilis Treponema pallidum infections within the Infectious Diseases Clinic at Washington University in St Louis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None