The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain during intracervical block
研究概览
简要总结
When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures.
Women being treated at the Women & Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.
The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.
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
- 否
入选标准
- •Patient at the Women and Infants Triage/Women's Emergency Department
- •Vital signs are stable
- •Ages 18 and older
- •Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
- •Estimated gestational age up to 10 weeks
- •Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
- •Able to read English or Spanish
- •Able to give informed consent for involvement in the study
排除标准
- •Allergic to lidocaine, iodine or betadine
- •Known sensitivity to any component of the lidocaine or placebo gel.
- •In acute distress
- •Unable to give informed consent
- •Unable to read English or Spanish
研究组 & 干预措施
Placebo gel
Placebo gel applied topically to the cervix
干预措施: Placebo gel (Drug)
Lidocaine gel
2% lidocaine gel applied topically to the cervix
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain during intracervical block
时间窗: immediate
Pain on visual analogue scale
次要结局
- Pain during tenaculum placement(immediate)
- Pain during cervical dilation(immediate)
- Pain during uterine aspiration(immediate)