Nexplanon Removal: Subcutaneous vs. Topical Lidocaine
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2020
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2020
CompletedFirst Submitted
Initial submission to the registry
July 8, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedJuly 10, 2020
July 1, 2020
3.4 years
July 8, 2020
July 8, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
pain of procedure
Using the pain scale the participant is asked to circle the numerical value of pain they had during removal.
during procedure
time to perform procedure
the medical assistant times the procedure from incision to removal of the device.
procedure
Secondary Outcomes (2)
How likely to recommend their anesthetic?
procedure
Provider's sense of ease of removal?
procedure
Study Arms (2)
EMLA
EXPERIMENTALSubjects 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
ACTIVE COMPARATORSubjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal.
Interventions
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.
Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Augusta University Ob/Gyn Resident Continuity Clinic
Augusta, Georgia, 30912, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Dept. of Obstetrics and Gynecology
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 10, 2020
Study Start
January 6, 2020
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
July 10, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share