Dural Puncture Epidural (DPE) Technique: Efficacy and Safety Overview.
ConditionLabor Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dural Puncture Epidural (DPE) Technique
Procedure/SurgeryAll 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Dural Puncture Epidural (DPE) Cohort1 intervention
Trial outcomes
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.
Time frame
During epidural placement procedure (at time of dural puncture)Secondary outcomes
1
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)
Time frame
Baseline (immediately before epidural placement) and immediately after completion of the DPE procedure.2
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.
Time frame
20 minutes after completion of the epidural loading dose.3
Maternal labor analgesia satisfaction score
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.
Time frame
Within 24 hours after delivery.4
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.
Time frame
At 1 and 5 minutes after birthSponsors and contacts
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Source ClinicalTrials.gov