Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion
研究概览
简要总结
For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.
排除标准
- •Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.
研究组 & 干预措施
Experimental, IUD Insertion group
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
干预措施: Vaginal 2% Lidocaine (Drug)
Control, IUD Insertion group
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
干预措施: Surgical Lubricant Jelly (Drug)
结局指标
主要结局
(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion
时间窗: 0-3 minutes after procedure completed
Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
次要结局
- Pain After Tenaculum Placement as Measured by a Visual Analog Scale(Intraoperative)
- Anticipated Pain as Measured by a Visual Analog Scale(30 Minutes prior to procedure)
- Baseline Pain as Measured by a Visual Analog Scale(Immediately prior to procedure; upon arrival to procedure room)
- Pain After Speculum Placement as Measured by a Visual Analog Scale(Intraoperative)
研究者
Jennifer Conti
Clinical Instructor
Stanford University