Nexplanon Removal: Subcutaneous vs. Topical Lidocaine

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.

Study Overview

• Status: Recruiting
• Conditions: Contraception
• Intervention / Treatment: Drug: Eutectic Lidocaine Prilocaine; Drug: Subcutaneous Lidocaine

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Manish Jain, MD; Phone Number: 706-721-2542; Email: majain@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University Ob/Gyn Resident Continuity Clinic
      • Contact: Manish Jain, MD; Phone Number: 706-721-2542; Email: majain@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: EMLA
Active Comparator: Subcutaneous Lidocaine; Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
How likely to recommend their anesthetic?	procedure
Provider's sense of ease of removal?	procedure

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Combined; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
• Other Study ID Numbers: 1288589-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No