An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Pain reported with cervical dilation
研究概览
简要总结
Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.
详细描述
The investigators expect to have 120 women complete this study, between study sites at OHSU's Center for Women's Health and Planned Parenthood Columbia Willamette in Portland, OR. Every participant will still receive the standard oral medication for pain (ibuprofen) and anxiety (lorazepam). Eligible subjects will be at least 18 years of age, less than 11 weeks pregnant and have already decided to have a surgical abortion.
The primary outcome evaluated will be pain reported at time of cervical dilation. The investigators will assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step and pain and satisfaction 30 minutes postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years or older
- •Voluntarily requesting pregnancy termination
- •Ultrasound confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
- •Good general health
- •English or Spanish speaking
- •Be able and willing to sign an informed consent and agree to terms of the study
排除标准
- •Gestational ages over 11 0/7 weeks, due to routine misoprostol use at our institutions
- •Incomplete abortion
- •Required or requested narcotics or IV sedation (prior to randomization)
- •Patients who refuse Ibuprofen and paracervical blocks
- •Contraindications or allergies to lidocaine, ibuprofen or ativan
- •Significant physical or mental health condition
- •Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
- •Patients with known hepatic disease
- •Women, who in the opinion of the investigator are not suitable for the study protocol
结局指标
主要结局
Pain reported with cervical dilation
时间窗: 1 Year
Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation.
次要结局
- Anxiety reported with the pain expected during the procedure and the procedure itself.(1 Year)
- Satisfaction reported with pain control and overall procedure(1 Year)
- Need for additional intraoperative and/or postoperative pain medication(1 Year)
- Anticipated and reported pain at various time points(1 Year)