"Comparison of Pain After Uterine Artery Embolization Using Spherical Gelfoam or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score (VAS score)
研究概览
简要总结
The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids
详细描述
Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The spherical gelfoam and tri-acryl gelatin microsphere are two embolic materials used for UAE. Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using the two embolic agents with symptomatic fibroids.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic fibroids (age: 20 - 60 years old)
排除标准
- •Bradycardia (<45 bpm)
- •Conduction abnormalities
- •Liver failure
- •renal failure
- •Uncontrolled hypertension
- •High grade obesity (BMI ≥ 30 kg/m2)
- •Drug allergy
结局指标
主要结局
Pain score (VAS score)
时间窗: up to 24 hours after embolization
Maximum pain score measured during 24 hours after embolization
次要结局
- C-reactive protein (mg/L)(the day before and 24 hours after embolization)
- Lymphocyte percentage (%)(the day before and 24 hours after embolization)
- Tumor necrosis rate after embolization(1 day and 3 months after embolization)
- Symptom severity questionnaire(before and 3 months after embolization)
- Cumulative fentanyl dose (µg)(within 24 hours after embolization)
- Use of rescue analgesics (%)(within 24 hours after embolization)
- Neutrophil percentage (%)(the day before and 24 hours after embolization)
- White blood cell count (/µL)(the day before and 24 hours after embolization)