Lidocaine for Pain Control During Intrauterine Device Insertion: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 123
- 主要终点
- Pain scores assessed by 10-point VAS scale
研究概览
简要总结
Despite being the most common method of contraception, the use of intrauterine devices (IUDs) is limited by the associated pain during insertion. Many pharmacologic interventions had been studied for their efficacy to reduce IUD insertion pain, of them, lidocaine was found to be superior over NSAIDs or other local anesthetics. This work aims at comparing the safety and efficacy of different lidocaine formulations to optimize selection in reduction of IUD associated pain.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Multiparous women.
- •Over 18 years of age and eligible for IUD insertion.
- •Application of IUD will be done in postmenstrual period.
排除标准
- •Null parity.
- •History of failed intrauterine device insertion (uterine perforation, acute expulsion).
- •Copper allergy.
- •Uterine anomaly.
- •Post-partum endometritis or septic abortion in the past three months.
- •Untreated cervicitis/vaginitis, including bacterial vaginosis.
- •Immunosuppression.
- •History of lidocaine ,prilocaine allergy.
- •Analgesic or anxiolytic use within the last 24 hours before the procedure.
- •Wilson's disease.
- •Suspicion of pregnancy.
- •Untreated abnormal uterine bleeding.
研究组 & 干预措施
Lidocaine spray Arm
This arm will receive lidocaine spray (Lidocaine topical aerosol ®, 10%, Arab drug co., Egypt) with dose four puffs (50 ml, 10 mg/puff) will be applied to the cervical canal and cervix.
干预措施: Lidocaine topical (Drug)
Lidocaine cream Arm
This arm will receive topical cream (Pridocaine ®, Global Napi, Egypt) with a dose of 2g lidocaine cream will be applied to the cervix via cotton swab.
干预措施: Lidocaine topical (Drug)
Lidocaine injection Arm
This arm will receive lidocaine injection (Debocaine®, 2%, Sigma-Tec, Egypt) with a dose of 80-200 mg equivalent to 10 ml lidocaine (20 mg/ml) is injected at four and eight o'clock of the cervico-vaginal junction, and 2 ml to the area to be grasped with the tenaculum for paracervical block.
干预措施: Lidocaine topical (Drug)
结局指标
主要结局
Pain scores assessed by 10-point VAS scale
时间窗: 1 year
VAS scores will be assessed on at three different points; baseline after application of speculum and analgesic administration, after grasping cervix with tenaculum, then following hysterometry and IUD insertion.
次要结局
- Patient satisfaction to IUD insertion(1 year)
研究者
Hadeer Abd-El Shafy Fouad
Resident physician
Ain Shams University