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NCT Number: NCT07793552

Needlefree Lidocaine Application for 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.

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Key information

Conditions

Vulvar Cancers Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vulva Neoplasm Vulvar Diseases Vulvar Dysplasia Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location contact

Afshin Azimirad, MD

CONTACT

[email protected]

6176369561

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People aged ≥18 years
  • Planned to undergo a vulvar biopsy in a gynecologic outpatient office
  • 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

  • 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.
  • Unable to provide informed consent.

Treatment and study plan

J-tip

Device

Vulvar biopsies are routinely performed to diagnose dysplasia and cancer of the vulva. There is no pathognomonic appearance to vulvar intraepithelial neoplasia (VIN) and so any abnormal appearing vulvar lesion should be biopsied. HPV-related vulvar dysplasia is increasing, with 2.86 per 1000 females in 2000. There are 6500 cases of vulvar cancer annually.

ACOG has outlined the urgent need for health care professionals to better understand pain management options for patients. Higher levels of preprocedural anxiety or expectations of pain are associated with higher levels of patient-reported pain with office procedures. Users of social media platforms share patient experiences with gynecological procedures that were painful and traumatic, and woman are calling for better pain management for gynecological procedures. Participants receiving topical lidocaine prilocaine had less pain but there was still pain. An optimal anesthetic use and delivery has not been identified.

Lidocaine HCl 1%

Drug

1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle

Primary outcomes

  1. Patient reported pain

    Time frame: between the administration of the lidocaine to immediately after the biopsy

    The primary outcome will be the highest patient reported pain score between the administration of the lidocaine to immediately after the biopsy. The 100mm visual analog scale will be utilized where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain).

Secondary outcomes

  1. Patient nervousness, experience and acceptability, and provider acceptability

    Time frame: before and after randomization, and the day after.

    Pain score at biopsy, patient nervousness before and after randomization, patient experience and acceptability, and provider acceptability and perfection of patient tolerance, using the 100mm visual analog scale (VAS) where pain is rated on a scale from

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

Needlefree Lidocaine JTip Application for Pain Optimization in Vulvar Biopsies

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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