Dural Puncture Epidural (DPE) Technique: Efficacy and Safety Overview.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dural Puncture Epidural (DPE) Technique.
- Who it may be relevant to
- Registry conditions: Labor Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Interventions
- Procedure Dural Puncture Epidural (DPE) Technique
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.
Primary outcome measures
- Success rate of dural puncture epidural (DPE) technique (CSF backflow) [Time frame: During epidural placement procedure (at time of dural puncture)]
Secondary outcome measures (4)
- Provider confidence score before and after DPE [Time frame: Baseline (immediately before epidural placement) and immediately after completion of the DPE procedure.]
- Epidural analgesia success rate [Time frame: 20 minutes after completion of the epidural loading dose.]
- Maternal labor analgesia satisfaction score [Time frame: Within 24 hours after delivery.]
- Neonatal Apgar scores [Time frame: At 1 and 5 minutes after birth]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The Ohio State University Wexner Medical Center Hospitals — Columbus
Identifiers
NCT: NCT07704554 · 2023H0437