Randomized Controlled Trial of Cervical Lidocaine for Intrauterine Device Insertion Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain Score Assessed Immediately Following IUD Insertion
研究概览
简要总结
The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.
详细描述
Double blind randomized controlled trial.
Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18-45 yrs
- •selecting intrauterine device contraception
- •able and willing to consent
排除标准
- •non-English speaking
- •current intrauterine device use
- •expulsion of intrauterine device within 2 weeks
- •allergy to lidocaine or water based lubricant
研究组 & 干预措施
2% Lidocaine gel
Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal
干预措施: 2% lidocaine gel (Drug)
Water based lubricant
Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal
干预措施: Water based lubricant (Drug)
结局指标
主要结局
Pain Score Assessed Immediately Following IUD Insertion
时间窗: Immediately following IUD insertion
Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required. Range: 0-10 (0= no pain, 10=worst pain)
次要结局
未报告次要终点