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

NCT07704554 | Recruiting

• 1 other identifier: 2023H0437
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Provider confidence score before and after DPE

  Baseline (immediately before epidural placement) and immediately after completion of the DPE procedure.

• Epidural analgesia success rate

  20 minutes after completion of the epidural loading dose.

• Maternal labor analgesia satisfaction score

  Within 24 hours after delivery.

• Neonatal Apgar scores

  At 1 and 5 minutes after birth

Study Arms (1)

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

Interventions

Dural Puncture Epidural (DPE) Technique PROCEDURE

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.

Dural Puncture Epidural (DPE) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center Hospitals

Columbus, Ohio, 43201, United States

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Goran Ristev

CONTACT

6142938487; goran.ristev@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 15, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-06

Locations

US (1)