Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.
详细描述
A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.
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)
盲法说明
pharmacy prepared sequentially numbered opaque bottles with identical capsules containing either placebo (vit c) or Gabapentin 600mg, block randomized
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
- •Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age.
- •English or Spanish speaking
- •eligible for office-based surgical pregnancy termination
排除标准
- •present use of gabapentin or pregabalin,
- •renal disease
- •sensitivity or allergy to gabapentin
- •Missed abortion
研究组 & 干预措施
Gabapentin Arm
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
干预措施: Gabapentin (Drug)
Placebo Arm
Placebo (vit C) given 1-2 hours prior to surgical abortion
干预措施: Placebos (Drug)
结局指标
主要结局
Pain Score
时间窗: 5 minutes postoperative
100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
次要结局
- Nausea(24 hours postoperative)
- Pain Score 24(24 hours postop)
- Vomiting(24 hours postoperative)
- Pain Score at 30 Minutes Postoperative(30 minutes postoperative)
研究者
Adam Levy
Associate Professor, OB/GYN
University of Nevada, Las Vegas