Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of adequate analgesia
研究概览
简要总结
Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor analgesia. The DPE technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural technique without the side effects observed with the CSE technique.
详细描述
Investigators designed this prospective interventional study to determine if morbid obesity would influence DPE technique regarding labor analgesia onset and block characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 - 45 years old,
- •Physical status American society of anesthesiology (ASA) II,
- •Vertex fetuses at 37-41 weeks' gestation,
- •Nulliparous and multiparous women,
- •Immediately before epidural placement, subjects marked a VNRS score during an active contraction and parturients with VNRS ≥ 50 were included
- •Cervical dilatation < 5 cm
排除标准
- •Contraindications to regional anesthesia
- •Refuse to participate
- •Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
- •Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery) and vaginal birth after cesarean delivery
结局指标
主要结局
Incidence of adequate analgesia
时间窗: 5 minutes
The primary outcome of this study is the incidence of patients having adequate analgesia (VNRS \<30) at 5 minutes of epidural activation
次要结局
- Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )(6 hours)
- Sensory level of DPE by pricking by blunt head of a pin(6 hours)
- Motor block Bromage score (1 being complete motor block and 6 being no motor block)(6 hours)
研究者
Raham Hasan Mostafa, MD
Assistant Professor
Ain Shams University