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.

Study Overview

• Status: Recruiting
• Conditions: Labor Pain
• Intervention / Treatment: Procedure: Dural Puncture Epidural (DPE) Technique

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Goran Ristev; Phone Number: 6142938487; Email: goran.ristev@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • The Ohio State University Wexner Medical Center Hospitals
      • Contact: Goran Ristev

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of dural puncture epidural (DPE) technique (CSF backflow)	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider confidence score before and after DPE	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	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.
Maternal labor analgesia satisfaction score	Patient-reported satisfaction with labor analgesia, measured using the institutional 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.
Neonatal Apgar scores	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

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain; Investigative Techniques; Methods
• Other Study ID Numbers: 2023H0437

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No