Nexplanon Removal: Subcutaneous vs. Topical Lidocaine

Contraception Clinical Trial

Official title:

Nexplanon Removal: Subcutaneous vs. Topical Lidocaine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467125
• Other study ID #: 1288589-4
• Status: Recruiting
• Phase: Phase 4
• Start date: January 6, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2020
• Source: Augusta University
• Contact: Manish Jain, MD
• Phone: 706-721-2542
• Email: majain[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Augusta University Ob/Gyn Resident Continuity Clinic	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain of procedure	Using the pain scale the participant is asked to circle the numerical value of pain they had during removal.	during procedure
Primary	time to perform procedure	the medical assistant times the procedure from incision to removal of the device.	procedure
Secondary	How likely to recommend their anesthetic?		procedure
Secondary	Provider's sense of ease of removal?		procedure