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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
106
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.
1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle
Tufts Medical Center
Boston, Massachusetts, United States
Patient reported pain
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).
Time frame: between the administration of the lidocaine to immediately after the biopsy
Patient nervousness, experience and acceptability, and provider acceptability
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
Time frame: before and after randomization, and the day after.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.