Paracervical Block With Lidocaine as a Modality to Decrease IUD Insertion Related Pain
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain at time of IUD insertion
研究概览
简要总结
Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion. Nulliparous women may be especially susceptible to procedure-related pain from IUD insertion. This study will investigate the difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. The investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of local anesthesia.
详细描述
The study will investigate the difference in perceived pain from IUD insertion, comparing paracervical block with lidocaine to a placebo (bacteriostatic saline) block, among nulliparous and "functionally nulliparous" women. The investigators plan a double-masked, placebo controlled, randomized clinical trial. The investigators anticipate that among patients who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of a 15 mL 1% lidocaine paracervical block compared to patients who receive 15 mL of bacteriostatic saline (placebo).
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
- 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
- •Nulliparous and "functionally nulliparous" women receiving their first IUD. "Functionally nulliparous" women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as <4 cm dilation).
- •English speaking
排除标准
- •Presence of a Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use category 3 or 4 precaution to a levonorgestrel IUD
- •chronic narcotic use, current or past history of illegal drug use (excluding marijuana)
- •allergy to lidocaine
研究组 & 干预措施
Lidocaine
Paracervical block using 15 mL of 1 % lidocaine
干预措施: Lidocaine (Drug)
Placebo
paracervical block using 15 mL of bacteriostatic saline
干预措施: Placebo (Drug)
结局指标
主要结局
Pain at time of IUD insertion
时间窗: During IUD insertion (no further follow up after patient leaves ofice)
Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment
次要结局
- Pain at other time points of pelvic exam(During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office))