Vapocoolant Application for Pain Reduction During Office-based Gynecologic Procedures: a Randomized Controlled Trial (VAPOR)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Pain With Paracervical Block
研究概览
简要总结
The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.
详细描述
After patients seen in our clinic have decided to proceed with a gynecology procedure that requires a paracervical block, the doctor will evaluate if the patient meets eligibility criteria for this study. If the patient does meet eligibility criteria, the doctor will inform the patient about the study and the potential risks. All patients will be given written informed consent. If the patient decides to participate in the study, they will be randomized (patient blinded) to receive either Num vapocoolant spray or placebo (normal saline spray), which the patient will receive during their gynecologic procedure just before the paracervical block. The purpose of this study is to see if the Num vapocoolant spray decreases patients pain with the paracervical block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Research coordinators who will be collecting pain scales from patients will be blinded to intervention assignment.
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
- •Age 18 years of age or older
- •Undergoing a procedure requiring paracervical block
- •English-speaking
- •Able and willing to sign the informed consent form and agree to terms of the study
排除标准
- •Required or requested narcotics, anxiolytics, IV sedation, or general anesthesia for the procedure
- •Declines or has a contraindication/allergy to ibuprofen
- •Previously received vapocoolant spray in a medical setting
- •Contraindications or allergies to lidocaine for paracervical block or vapocoolant spray components (1,1,3,3-pentafluoropropaine or 1,1,1,2-tetrafluroethane)
结局指标
主要结局
Pain With Paracervical Block
时间窗: Immediately after paracervical block (0 minutes after PCB completed)
The investigators will ask patients to rate their pain with the paracervical block using a visual analog scale (VAS). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no pain, 100 is marked as worst pain.
次要结局
- Pre Procedure Anxiety(Immediately after enrollment - before procedure)
- Other Pain Points During Gynecology Procedure(Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after procedure)
- Patient Satisfaction With Procedure(Immediately after their gynecologic procedure (0 minutes after procedure completed))
- Provider Ease of Use(Within 5 minutes after patient procedure)
- Pre Procedure Anxiety(Immediately after enrollment - before procedure)
研究者
Catherine Rault
Complex Family Planning Fellow
Queen's Medical Center