The Effect of Intracervical Lidocaine Injection Versus Topical Lidocaine Gel on the Pain Experienced by Patients Undergoing Tenaculum Application to the Cervix at the Time of an Office Gynecologic Procedure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Tenaculum Pain
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women are with the method of pain control used.
The researchers hypothesize that:
- There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.
- Patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.
详细描述
Subjects who have already scheduled an IUD insertion or endometrial biopsy will be asked to join this study assessing two pain control interventions at the time of tenaculum application to the cervix during office gynecologic procedures. Only healthy women ages 18 and over with an indication for endometrial biopsy or IUD placement will be recruited. The participants will be randomized to one of two arms: an intracervical lidocaine injection versus topical lidocaine gel. They will be asked to indicate their level of pain and level of satisfaction using a Visual Analog Scale. The primary outcome, pain with tenaculum placement, and the secondary outcome, satisfaction with the experience of tenaculum placement, will be compared between the study groups.
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)
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
- •Generally healthy women
- •Age 18 and over
- •Indication for endometrial biopsy or IUD placement
排除标准
- •Allergy to lidocaine or other local anesthetic
- •Pregnancy, known or suspected
- •Patients who are premedicated with misoprostol
- •Patients with a chronic pain condition for which the patient takes daily pain medication
研究组 & 干预措施
Intracervical Lidocaine Injection
Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle.
干预措施: Intracervical Lidocaine Injection (Drug)
Topical Lidocaine Gel
Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip (this amount of lidocaine will be measured out prior to procedure)
干预措施: Topical Lidocaine Gel (Drug)
结局指标
主要结局
Tenaculum Pain
时间窗: After tenaculum placement
The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.
次要结局
- Tenaculum Placement Satisfaction(After placement of the tenaculum)
- Intervention Pain(after application of randomized intervention)
研究者
Paula Bednarek
MD MPH
Oregon Health and Science University