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

2026년 7월 17일 업데이트: 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.

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

150

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Ohio
      • Columbus, Ohio, 미국, 43201
        • 모병
        • The Ohio State University Wexner Medical Center Hospitals
        • 연락하다:
          • Goran Ristev

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

해당 없음

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Success rate of dural puncture epidural (DPE) technique (CSF backflow)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Provider confidence score before and after DPE
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 10월 1일

기본 완료 (추정된)

2028년 1월 31일

연구 완료 (추정된)

2028년 1월 31일

연구 등록 날짜

최초 제출

2026년 7월 1일

QC 기준을 충족하는 최초 제출

2026년 7월 9일

처음 게시됨 (실제)

2026년 7월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 17일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

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아니

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