A Comparison of Intrauterine Lidocaine Infusion and Paracervical Block for Pain Management in First Trimester Abortions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.
研究概览
简要总结
The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).
详细描述
The Investigators intend to conduct a randomized, patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Women will be approached about this study after they have made a decision to terminate the pregnancy. The women will be blinded and randomized into one of two study arms.
Group 1: the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 o'clock. This will approximate the steps involved in a paracervical block without injecting the patient. Following this, the patient will receive a 5 milliliter intrauterine infusion of 4% lidocaine using a sterile 3mm Novak curette. The infusion will be placed slowly over 3 minutes.
Group 2: a standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Following this, a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes. The curette will not be placed through the cervix and no infusion will be performed. This will approximate the steps involved in an intrauterine infusion without injecting the patient.
During the procedure, women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Good general health
- •Age>18years
- •English speaking
- •Voluntarily requesting pregnancy termination
- •Have an estimated gestation of up to 76 days since the first day of the preceding menstrual period
- •Confirmed by ultrasound
- •Be able and willing to sign an informed consent
- •Agree to the terms of the study
- •All patients must be premedicated with Ibuprofen and Valium (per clinic protocols)
排除标准
- •Significant physical or mental health condition
- •A gestational age of 77 days or more
- •Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
- •Patients who require or request IV/intramuscular sedation
- •Patients who refuse Ibuprofen, Valium and/or paracervical blocks
- •Patients allergic to lidocaine
- •Patients with known hepatic disease
- •Patients weighing less than 100 lbs
研究组 & 干预措施
Lidocaine infusion
5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
干预措施: Lidocaine (Drug)
Paracervical block only
Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
干预措施: Lidocaine (Drug)
结局指标
主要结局
The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.
时间窗: Immediately (time zero) at uterine aspiration
Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).
次要结局
未报告次要终点
研究者
Alison Edelman
Assistant Professor
Oregon Health and Science University