Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT07704554

Conditions

Labor Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dural Puncture Epidural (DPE) Technique

Study Details

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

Study ID

NCT07704554

Start date

Oct 1, 2024

Status verified date

Jun, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Success rate of dural puncture epidural (DPE) technique (CSF backflow) [ Time Frame: During epidural placement procedure (at time of dural puncture) ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University Wexner Medical Center Hospitals

Recruiting

Columbus, Ohio, United States, 43201

More Information

Sponsor

Ohio State University

Last update posted

Jul 20, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-20.