Recruiting

Subcutaneous vs. Topical Lidocaine

Sponsor:

Augusta University

Code:

NCT04467125

Conditions

Contraception

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Eutectic Lidocaine Prilocaine

Subcutaneous Lidocaine

Study Details

Brief summary:

A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure and time to removal.

Conditions

Contraception

Study ID

NCT04467125

Start date

Jan 6, 2020

Status verified date

Jul, 2020

Completion date

May 31, 2023

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Females with Nexplanon implant in place, desiring removal No allergy to lidocaine or any component of EMLA cream Age greater than or equal to 18years English as primary language Not pregnant

Exclusion Criteria:

  • pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: EMLA

Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.

active comparator: Subcutaneous Lidocaine

Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal.

Interventions

Eutectic Lidocaine Prilocaine

Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.

Subcutaneous Lidocaine

Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider.

Primary outcome measure

  • pain of procedure [ Time Frame: during procedure ]
  • time to perform procedure [ Time Frame: procedure ]

Central Contacts and Locations

Central contacts

Manish Jain, MD

706-721-2542majain@augusta.edu

Locations

Augusta University Ob/Gyn Resident Continuity Clinic

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Manish Jain, MD

706-721-2542majain@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jul 10, 2020

Last verified

Jul, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2020-07-10.