Dural Puncture Epidural Technique vs. Standard Epidurals vs. Combined-Spinal Epidurals for Cesarean Sections: Does it Really Matter to the Patient?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group
研究概览
简要总结
The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.
详细描述
There are approximately 4 million child birth deliveries in US hospitals per year, and 1.3million of those births are via cesarean section (c-section). With this type of surgery, obstetric anesthesiology plays an important role. The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female parturient at Grady Memorial Hospital must meet one of the following:
- •Parturient having a scheduled or elective cesarean section
- •Parturient not having primary cesarean-section
- •At least 18 years of age
- •Subject has signed the informed consent
排除标准
- •Parturient who is unable or unwilling to sign the consent form
- •Parturient having primary cesarean section
- •Parturient with known complex cardiac disease (ex...aortic/mitral stenosis, aortic aneurysms, congenital heart disease with residual defects...etc)
- •Parturient with any contraindication to neuraxial anesthesia such as coagulopathy, infection, or patient refusal
- •Parturient having a fourth or more cesarean section
结局指标
主要结局
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group
时间窗: 1 hour after procedure
The blinded investigator will visit the patient within 1hour of block placement and ask to select Numeric Pain Rating Score (NPRS) (1-10) during procedure.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Percent of patients with Numeric Pain Rating Score (NPRS) <3 in the DPE vs. EPI group.
时间窗: 1 hour after procedure
The blinded investigator will visit the patient 3 hours within 1hour of block placement and ask to select Numeric Pain Rating Score (NPRS) (1-10) during procedure.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. EPI group
时间窗: 1 hour after procedure
The blinded investigator will visit the patient within 1hour of block placement and ask to select Numeric Pain Rating Score (NPRS) (1-10) during procedure. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Scores range from 0-10 points, with higher scores indicating greater pain intensity.
次要结局
- Percent of patients required rescue analgesia in the DPE vs. EPI group(During labor/delivery (up to 24 hours))
- Percent of patients required rescue analgesia in the DPE vs. CSE group(During labor/delivery (up to 24 hours))
研究者
Dawn Manning-Williams
Assistant Professor
Emory University