Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale
研究概览
简要总结
Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions.
The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial.
If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.
详细描述
Abortion remains one of the most common surgical procedures in the world, regardless of region or development status [Guttmacher 2012]. In the United States, at least half of all women will experience an unintended pregnancy by age 45, and one third of all women will have had an abortion by this same age [Guttmacher 2014].
Despite universal efforts to increase the comfort of these procedures, pain remains a limiting factor in where and how abortion is performed. Recent estimates reveal that 70-97% of women experience pain during abortion [Renner 2010, Paul 2009, Belanger 1988]. Strategies to reduce all aspects of abortion related pain have the potential for significant public health impact, given the large number of women who seek these services. A survey of National Abortion Federation clinics found that to date, most providers (84%) employ the use of a lidocaine paracervical block for cervical anesthesia prior to abortion [O'Connell 2009], but traditionally without a waiting period between lidocaine administration and procedure initiation.
To the best of our knowledge, there are no published studies that 1) rigorously examine the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explore whether adequate pain relief is possible through self-administered, non-invasive means alone. The investigators propose to explore the effect of a locally applied lidocaine gel in place of the traditional paracervical block to decrease abortion related pain.
The objective of this study is to compare pain control at various time points during first trimester surgical abortion using a locally applied, patient-administered lidocaine gel as compared to traditional lidocaine paracervical block.
If a patient-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures, and perhaps replace paracervical injection altogether.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active Comparator
Drug: vaginal 2% Xylocaine
干预措施: vaginal 2% Xylocaine (Drug)
standard lidocaine paracervical block
standard lidocaine paracervical block
干预措施: standard lidocaine paracervical block (Drug)
结局指标
主要结局
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale
时间窗: At time of cervical dilation, 30 minutes after lidocaine administration
This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
次要结局
- Pain With Tenaculum Placement as Measured by a Visual Analog Scale(Pain at time of tenaculum placement)
- Overall Satisfaction With Procedure as Measured by a Visual Analog Scale(30-45 minutes after completion of procedure)
- Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale(Pain prior to discharge home: 30-45 minutes after completion of procedure)
- Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale(Pain level prior to procedure)
- Pain With Speculum Insertion as Measured by a Visual Analog Scale(Pain at time of speculum insertion)
- Overall Complication Rate as Measured by a Count of Participants in Each Group(Rate of complications at the end of the study)