Topical Anesthetic Use In Pessary Management: A Randomized Double Blinded Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
研究概览
简要总结
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.
详细描述
Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream.
Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
- •Read and speak the English language
排除标准
- •Non-English speaking
- •Allergy or contraindication to topical anesthetic
- •Participation/randomization in the study at a previous visit
- •Currently pregnant or lactating or planning a pregnancy within the next 6 months
研究组 & 干预措施
lidocaine-prilocaine
4 mL of lidocaine-prilocaine cream
干预措施: lidocaine-prilocaine cream (Drug)
Placebo
4 mL of placebo cream
干预措施: Placebo cream (Drug)
结局指标
主要结局
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
时间窗: Removal of Pessary
Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
次要结局
- VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training(Removal of Pessary)
- VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain(Insertion of Pessary)
- VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age(Removal of Pessary)
研究者
Cynthia Brincat
Assistant Professor
Loyola University