Nexplanon Removal: Subcutaneous vs. Topical Lidocaine

NCT ID: NCT04467125

Last Updated: 2020-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Eutectic Lidocaine Prilocaine

Intervention Type DRUG

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 at the removal site and then undergo Nexplanon removal.

Group Type ACTIVE_COMPARATOR

Subcutaneous Lidocaine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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EMLA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Manish Jain

Associate Professor, Dept. of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Augusta University Ob/Gyn Resident Continuity Clinic

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manish Jain, MD

Role: CONTACT

706-721-2542

Facility Contacts

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Manish Jain, MD

Role: primary

706-721-2542

Other Identifiers

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1288589-4

Identifier Type: -

Identifier Source: org_study_id

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