Needlefree Lidocaine Application for Vulvar Biopsies

Needlefree Lidocaine JTip Application for Pain Optimization in Vulvar Biopsies

The goal of this study is to compare pain during a vulvar biopsy using either the needle-free J-Tip device or the standard lidocaine shot. We expect to enroll up to 106 subjects will be enrolled in this study at Tufts Medical Center. The study will take place in a gynecology clinic or outpatient medical office where your biopsy is already scheduled. You will be asked to review and sign a consent form before joining the study. You will then complete a short survey about your background, pain level, and anxiety. During your visit, you will be randomly assigned (like flipping a coin) to receive numbing medicine either through a needle-free device (J-Tip) or a standard injection. The numbing medicine will be given before your vulvar biopsy. You will be asked to rate your pain and nervousness at different times at the beginning and after the procedure using a simple scale. After the biopsy, you will complete a short survey about your experience. Your doctor will also record details about the procedure. The day after your biopsy, you will be asked to complete one more short survey about your pain and overall experience.

Inclusion Criteria:

1. People aged ≥18 years
2. Planned to undergo a vulvar biopsy in a gynecologic outpatient office
3. Individuals need to be able to provide informed consent. Consents will be available in English and interpretative services will be available in clinic visits to review the consent in other languages.

Exclusion Criteria:

1. Patients actively receiving chemotherapeutic agents as this is a contraindication for J-Tip use due to concerns of increased incidence of tissue necrosis and bleeding.
2. Unable to provide informed consent.