Dural Puncture Epidural (DPE) Technique: Efficacy and Safety Overview.
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Goran Ristev
- Numer telefonu: 6142938487
- E-mail: goran.ristev@osumc.edu
Lokalizacje studiów
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Ohio
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Columbus, Ohio, Stany Zjednoczone, 43201
- Rekrutacyjny
- The Ohio State University Wexner Medical Center Hospitals
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Kontakt:
- Goran Ristev
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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.
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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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Success rate of dural puncture epidural (DPE) technique (CSF backflow)
Ramy czasowe: During epidural placement procedure (at time of dural puncture)
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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.
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During epidural placement procedure (at time of dural puncture)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Provider confidence score before and after DPE
Ramy czasowe: Baseline (immediately before epidural placement) and immediately after completion of the DPE procedure.
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Anesthesia provider confidence rated on a 3-point scale (1 = not confident, 2 = somewhat confident, 3 = very confident)
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Baseline (immediately before epidural placement) and immediately after completion of the DPE procedure.
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Epidural analgesia success rate
Ramy czasowe: 20 minutes after completion of the epidural loading dose.
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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.
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20 minutes after completion of the epidural loading dose.
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Neonatal Apgar scores
Ramy czasowe: At 1 and 5 minutes after birth
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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.
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At 1 and 5 minutes after birth
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Maternal labor analgesia satisfaction score
Ramy czasowe: Within 24 hours after delivery.
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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.
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Within 24 hours after delivery.
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2023H0437
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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