此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Dural Puncture Epidural (DPE) Technique: Efficacy and Safety Overview.

2026年7月17日 更新者:Goran Ristev、Ohio State University

Neuraxial techniques such as lumbar epidural and combined spinal-epidural (CSE) are the most effective methods for labor analgesia and are associated with high patient satisfaction. However, standard epidurals can have failure rates and may be difficult to reliably confirm correct placement.

The dural puncture epidural (DPE) technique has been introduced to improve confirmation of epidural placement and potentially enhance analgesia. It involves identifying the epidural space, puncturing the dura with a spinal needle without injecting medication, confirming cerebrospinal fluid flow, and then placing the epidural catheter. While DPE may improve analgesia and drug spread, current evidence is limited and does not clearly demonstrate superiority over standard epidural techniques.

At The Ohio State Wexner Medical Center, DPE is used routinely for labor epidurals. This observational study evaluates epidural failure rates and anesthesia provider confidence in performing DPE, while also collecting procedural details, patient characteristics, analgesic outcomes, and complications. Provider confidence is assessed using a 3-point scale along with factors influencing performance, and patient outcomes include pain relief, need for rescue dosing, and overall epidural effectiveness.

研究概览

详细说明

This is a single-center, prospective observational study conducted at The Ohio State University Wexner Medical Center to evaluate the effectiveness and safety of the dural puncture epidural (DPE) technique for labor analgesia.

Neuraxial analgesia is the gold standard for pain relief during labor, with conventional epidural (CE) and combined spinal-epidural (CSE) being the most commonly used techniques. The DPE technique is a modification of the CSE approach in which the dura is intentionally punctured with a spinal needle to confirm correct epidural needle placement through visualization of cerebrospinal fluid (CSF), but no medication is injected into the intrathecal space. This approach is thought to improve epidural placement accuracy, enhance analgesia, and reduce epidural failure while maintaining the safety profile of a conventional epidural. Although DPE has gained widespread clinical use, current evidence regarding its superiority over conventional epidural techniques remains limited and inconsistent.

The primary objective of the study is to determine the success rate of the DPE technique, defined by successful visualization of CSF following dural puncture. Secondary objectives include evaluating epidural success following successful and unsuccessful DPE, anesthesia provider confidence before and after the procedure, labor analgesia effectiveness, maternal satisfaction with pain management, need for rescue analgesia, delivery outcomes, neonatal outcomes (Apgar scores and NICU admission), and procedure-related complications.

The study will enroll approximately 150 term pregnant patients requesting labor epidural analgesia and anesthesia care providers with prior epidural experience. Since DPE is already the institutional standard of care, participation in the study does not alter patient management. Instead, data are collected prospectively from routine clinical care, while participating anesthesia providers complete brief surveys assessing their confidence, procedural details, and technical success.

Clinical data collected include maternal demographics, obstetric characteristics, labor analgesia outcomes, epidural performance measures, rescue analgesia requirements, delivery mode, neonatal outcomes, and complications such as post-dural puncture headache, unilateral block, accidental dural puncture, catheter-related issues, or persistent neurologic symptoms. Epidural success is defined by adequate pain relief (pain score ≤3) and appropriate bilateral sensory blockade within 20 minutes after the loading dose.

Descriptive statistics will summarize patient and procedural characteristics, while comparative analyses will evaluate differences in outcomes between successful and unsuccessful DPE procedures. Overall, this study aims to better characterize the clinical performance of the DPE technique, determine its impact on epidural success and patient outcomes, and assess anesthesia provider confidence in performing the procedure under routine clinical practice.

研究类型

观察性的

注册 (估计的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ohio
      • Columbus、Ohio、美国、43201
        • 招聘中
        • The Ohio State University Wexner Medical Center Hospitals
        • 接触:
          • Goran Ristev

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

The study population consists of adult parturient women at term (37-42 weeks gestation) with singleton, vertex-presenting fetuses who request labor epidural analgesia at The Ohio State Wexner Medical Center. Eligible participants include patients with intact membranes or rupture of membranes within 6 hours who provide informed consent. The study also includes anesthesia care providers performing the dural puncture epidural (DPE) technique as part of routine clinical care. Patients with contraindications to neuraxial anesthesia, chronic pain management, spinal abnormalities or prior spine surgery, infection, or other exclusion criteria will be excluded.

描述

Inclusion Criteria:

  • o Women with a single vertex presentation fetus at term (37-42 weeks) with intact fetal membranes or membrane rupture <6 hours previously, who request to have an epidural for labor analgesia and provide written consent for the study.

Exclusion Criteria:

  • o Patients being treated/managed for chronic pain.

    • Allergies or significant adverse reactions to local anesthetic or opioid medications
    • Contraindication to labor epidural placement
    • Patients with history of spine abnormalities or spine surgery.
    • Prisoners
    • Clinical signs or symptoms of infection.
    • Non-English speakers.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Dural Puncture Epidural (DPE) Cohort
All eligible anesthesia care providers and laboring patients receiving the dural puncture epidural (DPE) technique as part of routine clinical care at The Ohio State Wexner Medical Center. Outcomes include epidural success/failure, procedural characteristics, and provider confidence.
All eligible anesthesia care providers and laboring patients receiving the dural puncture epidural (DPE) technique as part of routine clinical care at The Ohio State Wexner Medical Center. Outcomes include epidural success/failure, procedural characteristics, and provider confidence.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Success rate of dural puncture epidural (DPE) technique (CSF backflow)
大体时间:During epidural placement procedure (at time of dural puncture)
To determine the proportion of parturient patients in whom successful dural puncture epidural (DPE) is achieved, defined as the presence of cerebrospinal fluid (CSF) backflow following intentional dural puncture using a spinal needle during epidural placement.
During epidural placement procedure (at time of dural puncture)

次要结果测量

结果测量
措施说明
大体时间
Provider confidence score before and after DPE
大体时间:Baseline (immediately before epidural placement) and immediately after completion of the DPE procedure.
Anesthesia provider confidence rated on a 3-point scale (1 = not confident, 2 = somewhat confident, 3 = very confident)
Baseline (immediately before epidural placement) and immediately after completion of the DPE procedure.
Epidural analgesia success rate
大体时间:20 minutes after completion of the epidural loading dose.
Epidural analgesia success is defined as a verbal rating scale (VRS) pain score ≤3 and bilateral sensory blockade between T10 and L1 within 20 minutes after completion of the epidural loading dose.
20 minutes after completion of the epidural loading dose.
Neonatal Apgar scores
大体时间:At 1 and 5 minutes after birth
Neonatal status will be assessed using the Apgar Score, which ranges from 0 to 10, with higher scores indicating better neonatal condition. Apgar scores will be recorded at 1 minute and 5 minutes after birth.
At 1 and 5 minutes after birth
Maternal labor analgesia satisfaction score
大体时间:Within 24 hours after delivery.
Patient-reported satisfaction with labor analgesia, measured using the institutional satisfaction scale ranging from 0 to 10, where 0 indicates not satisfied at all and 10 indicates completely satisfied.postpartum labor analgesia satisfaction questionnaire (or specify the validated questionnaire used, if applicable). Satisfaction scores will be reported according to the questionnaire's scoring system.
Within 24 hours after delivery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月1日

初级完成 (估计的)

2028年1月31日

研究完成 (估计的)

2028年1月31日

研究注册日期

首次提交

2026年7月1日

首先提交符合 QC 标准的

2026年7月9日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅