Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation
研究概览
简要总结
The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.
详细描述
This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, 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
- Triple (Participant, Care Provider, 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
- •surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;
- •English or Spanish speaking;
- •ability to give informed consent
排除标准
- •pre-operative use of misoprostol;
- •allergy to study medications (lidocaine, prilocaine, versed, fentanyl);
- •known uterine anomaly;
- •prior cervical surgery
研究组 & 干预措施
Lidocaine-prilocaine cream
5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe
干预措施: Lidocaine-Prilocaine Cream (Drug)
Lidocaine-prilocaine cream
5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe
干预措施: 1% Lidocaine Paracervical Block (Drug)
Placebo cream (pain lucubrating gel)
5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe
干预措施: Placebo Cream (Drug)
Placebo cream (pain lucubrating gel)
5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe
干预措施: 1% Lidocaine Paracervical Block (Drug)
结局指标
主要结局
Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation
时间窗: Intraoperative; Immediately following cervical dilation
次要结局
未报告次要终点