The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block: Comparative Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Onset of analgesia
研究概览
简要总结
The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications.
详细描述
- 81 patients primigravida parturients (ASA II) in active labor
- uncomplicated pregnancy
- Cephalic presentation
- Cervical dilatation <5 cm
Exclusion criteria:
- Allergy to local anesthetics.
- Bleeding disorders
- Low platelet count
- Local or systemic sepsis
- Prior surgery in lumbosacral spine
- Patient's refusal.
Eighty-one patients meeting the inclusion criteria were randomly divided into three equal groups:
Group CE (n=27): Conventional epidural. Group DPE-25 (n=27): Dural puncture epidural with 25-gauge spinal needle. Group DPE-27 (n=27): Dural puncture epidural with 27-gauge spinal needle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelope will be opened by the nurse, the card inside will determine the patient group.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASAI & II parturient in active labor
- •Uncomplicated pregnancy with vertex presentation
- •Willing to participate in the study.
排除标准
- •Patient's refusal
- •Coagulopathy (INR> 1.5 and platelets < 80,000)
- •Allergy to local anesthetics.
- •Prior surgery in lumbosacral spine.
研究组 & 干预措施
DPE-27G group
Dural puncture epidural with 27-gauge spinal needle.
干预措施: Epidural analgesia (Procedure)
Conventional epidural group
Conventional epidural.
.
干预措施: Epidural analgesia (Procedure)
DPE-25G group
Dural puncture epidural with 25-gauge spinal needle.
干预措施: Epidural analgesia (Procedure)
结局指标
主要结局
Onset of analgesia
时间窗: 20 minutes
Duration from injection of the first initial epidural bolus dose to attainment of VAS \<3
次要结局
- Degree of analgesia(5 hours)
研究者
Reham Mahrous
Assistant professor
Cairo University