Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patient-reported pain level
研究概览
简要总结
The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are:
- Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration?
- Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.
详细描述
This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement. Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure. The tampon will be removed as the subject prepares for the procedure.
The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure. This data will be evaluated to compare the lidocaine to the control group.
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, Care Provider)
盲法说明
Study medication provided per randomization table. Study participants allocated sequentially. Subject and provider blinded to allocation
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Request IUD insertion
- •Age 18 or older
- •Willingness to return for procedure after completing virtual study consent
排除标准
- •Known allergy to viscous lidocaine or tampons
- •Current vaginal or cervical injury
研究组 & 干预措施
Aqueous lidocaine
Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement.
干预措施: Lidocaine topical (Drug)
Aqueous lidocaine
Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement.
干预措施: Tampon (Device)
Saline
Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement.
干预措施: Tampon (Device)
结局指标
主要结局
Patient-reported pain level
时间窗: Obtained immediately after the procedure prior to the patient leaving the clinic
0-10 Visual analog scale
Procedure time
时间窗: Measured during procedure
Time from uterine sounding to cutting strings (to allow for procedures where an IUD is removed prior to placing a new IUD)
次要结局
- Patient-reported satisfaction with procedure(Obtained immediately after the procedure prior to the patient leaving the clinic)
- Provider-reported procedural difficulty(Obtained immediately after the procedure prior to the patient leaving the clinic)
- Patient-reported interest in subsequent procedure(Obtained immediately after the procedure prior to the patient leaving the clinic)
研究者
Mike Arnold
Associate Professor
Uniformed Services University of the Health Sciences