Needlefree Lidocaine JTip Application for Pain Optimization in Vulvar Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Patient reported pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
J-Tip
A baseline questionnaire including demographics and baseline pain and anxiety levels will be administered. Pain scores will be reported using the 100mm visual analog scale (VAS) where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain). Pre-procedure nervousness will be measured in a similar fashion on a 100-mm VAS. Both will be measured at multiple time points during the procedure. Baseline anxiety will be measured using the validated Generalized Anxiety Disorder 7-item questionnaire. One administration of the J-Tip applicator filled with 1% lidocaine will be administered to the anticipated site of biopsy. A vulvar biopsy punch biopsy size of 3mm or 4mm will be utilized per standard of care. After the procedure and the following day, the patient will complete a brief questionnaire about the pain score, overall acceptability and tolerability.
干预措施: J-Tip (Device)
Standard Lidocaine Injection
A baseline questionnaire including demographics and baseline pain and anxiety levels will be administered. Pain scores will be reported using the 100mm visual analog scale (VAS) where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain). Pre-procedure nervousness will be measured in a similar fashion on a 100-mm VAS. Both will be measured at multiple time points during the procedure. Baseline anxiety will be measured using the validated Generalized Anxiety Disorder 7-item questionnaire. per standard of care, then 1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle. A vulvar biopsy punch biopsy size of 3mm or 4mm will be utilized per standard of care. After the procedure and the following day, the patient will complete a brief questionnaire about the pain score, overall acceptability and tolerability.
干预措施: Lidocaine HCl 1% (Drug)
结局指标
主要结局
Patient reported pain
时间窗: 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).
次要结局
- Patient nervousness, experience and acceptability, and provider acceptability(before and after randomization, and the day after.)