Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration
研究概览
简要总结
Paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. Other than some non-pharmacologic modalities (music and visualization), only the addition of intravenous medication has been shown to reduce procedural pain. Applied topical heat is effective in alleviating pain in other medical subspecialties, and in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for intraoperative pain control during first trimester abortion.
The investigators plan to conduct a double-blinded, randomized, controlled trial investigating the utility of topical heat application as an adjunct to paracervical block in first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score, measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators will look at the effect of heat application on pain at time of speculum placement, paracervical block, tenaculum placement, cervical dilation and overall pain. Patient satisfaction will also be assessed. If found to reduce pain during abortion under local anesthesia, the use of heat could offer an inexpensive, safe and universally available adjunct to the paracervical block during this procedure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 51 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age of 12 6/7 wks or less by ultrasound
- •Age 16 years or older
- •Requesting pregnancy termination by surgical abortion
- •Eligible for outpatient pregnancy termination
- •Able to provide informed consent
- •English or Spanish* speaking *If research assistant hired for project is bilingual
- •Electing local anesthesia only
排除标准
- •Reports active bleeding or severe pain at time of enrollment
- •Early pregnancy failure identified on pre-operative ultrasound
- •Skin irritation or rash over lower abdomen
- •Presumed molar pregnancy
- •Possible ectopic pregnancy
- •Electing intravenous sedation
- •Planned intra-operative sonographic guidance
结局指标
主要结局
pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration
时间窗: collected at time of procedure.
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded.
次要结局
- pain score measured on VAS at time of speculum placement(collected at time of procedure.)
- pain score measured on VAS at time of paracervical block(collected at time of procedure.)
- pain score measured on VAS at time of tenaculum placemenet(collected at time of procedure.)
- pain score measured on VAS at time of cervical dilation(collected at time of procedure.)
- overall pain scores will be measured on VAS at the conclusion of the procedure(collected at conclusion of procedure.)
- overall satisfaction with pain management will be measured on a 5 point Likert scale(collected at conclusion of procedure)