Dural Puncture Epidural vs Standard Epidural Analgesia in Labor (DPE-LABOR)

A Randomized Prospective Trial Comparing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia for Labor in Term Pregnant Women"

This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Labor Pain; Analgesia, Epidural
• Intervention / Treatment: Procedure: Dural Puncture Epidural (DPE); Procedure: Standard Epidural Analgesia

Detailed Description

This prospective randomized clinical trial is designed to compare the efficacy and safety of Dural Puncture Epidural (DPE) analgesia with Standard Epidural Analgesia in term laboring women requesting neuraxial analgesia. The DPE technique involves performing a dural puncture with a 27-gauge Whitacre spinal needle through the Tuohy epidural needle before catheter placement, without administering any intrathecal medication. In both groups, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered following a negative epidural test dose.

The primary objective of the study is to determine whether DPE provides a faster onset and higher quality of labor analgesia compared with the conventional epidural technique. Secondary objectives include evaluating maternal hemodynamic changes, sensory and motor block characteristics, the need for additional bolus doses, total local anesthetic consumption, maternal side effects (hypotension, nausea, vomiting, pruritus, urinary retention), post-dural puncture headache, fetal heart rate changes, Apgar scores, duration of labor, and overall patient satisfaction.

Term pregnant women aged 18-45 years with cervical dilation ≥4 cm, effacement ≥50-60%, and baseline VAS ≥3 will be included. Exclusion criteria include hypertensive disorders of pregnancy, placental abnormalities, contraindications to neuraxial anesthesia, morbid obesity (BMI ≥40), drug allergy, opioid dependence, or accidental dural puncture with the epidural needle. Eligible participants will be randomly assigned to either the DPE group or the Standard Epidural group in a 1:1 ratio. All procedures will be performed at the Gazi Yaşargil Training and Research Hospital by anesthesiologists experienced in obstetric neuraxial techniques, and data will be collected by an independent observer not involved in the block procedure.

The study aims to contribute to the growing body of evidence on optimizing labor analgesia techniques by determining whether the DPE approach leads to improved analgesic effectiveness, greater maternal comfort, and stable maternal-fetal outcomes compared with standard epidural analgesia.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Outside of the US
    • Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
      • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Term pregnant women (≥37 weeks of gestation).
2. Requesting neuraxial labor analgesia.
3. Age between 18 and 45 years.
4. ASA physical status I-II.
5. Cervical dilation ≥ 4 cm at the time of enrollment.
6. Cervical effacement ≥ 50-60%.
7. Baseline pain score of VAS ≥ 3.
8. Ability to provide informed consent.

Exclusion Criteria:

1. Hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia).
2. Placental abnormalities (placenta previa, placental abruption, etc.).
3. Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
4. Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
5. Morbid obesity (Body Mass Index ≥ 40 kg/m²).
6. Opioid dependence or chronic opioid use.
7. Accidental dural puncture with the epidural needle prior to randomization.
8. Multiple gestation or non-cephalic presentation (if clinically relevant to your protocol).
9. Fetal distress at the time of enrollment.
10. Patient refusal to participate.

11. Any condition deemed by the investigator to pose increased risk or interfere with study outcomes.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dural Puncture Epidural (DPE); Participants receive Dural Puncture Epidural analgesia using a 27G Whitacre spinal needle inserted through the Tuohy needle before epidural catheter placement, without intrathecal drug administration.	Procedure: Dural Puncture Epidural (DPE); The Dural Puncture Epidural (DPE) technique is performed by inserting a 27-gauge Whitacre spinal needle through the Tuohy epidural needle to puncture the dura without intrathecal drug injection. After removal of the spinal needle, an epidural catheter is placed, and following a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
Active Comparator: Standard Epidural Analgesia; Participants in this arm receive Standard Epidural Analgesia. The epidural block is performed using a Tuohy needle without dural puncture, and an epidural catheter is inserted into the epidural space. After a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.	Procedure: Standard Epidural Analgesia; Standard Epidural Analgesia is performed using a Tuohy needle without dural puncture. An epidural catheter is inserted into the epidural space, and after a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Onset of Effective Analgesia (VAS < 3)	Time in minutes from the administration of the initial epidural bolus until the patient reports a pain score of VAS < 3, indicating effective labor analgesia.	Within 30 minutes after epidural bolus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Block Level	The highest dermatome level of sensory block assessed by pinprick or cold test.	Within 30 minutes after epidural bolus
Motor Block Score (Bromage Score)	Degree of motor block measured using the Bromage scale (0-3).	Within 30 minutes after epidural bolus
Need for Additional Epidural Bolus	Number of additional boluses required when VAS ≥ 4.	During labor until delivery
Time to First Additional Bolus	Total amount (mL) of local anesthetic administered during labor.	From initiation of analgesia to delivery
Maternal Hemodynamic Changes	Changes in systolic/diastolic blood pressure and heart rate compared to baseline	First 30 minutes after epidural bolus
Maternal Side Effects	Incidence of hypotension, nausea, vomiting, pruritus, urinary retention, or other complications.	During labor until delivery
Post-Dural Puncture Headache (PDPH)	Presence or absence of typical post-dural puncture headache symptoms.	Day 3 and Day 7 postpartum
Fetal Heart Rate Changes	Any abnormal fetal heart rate patterns following neuraxial analgesia.	During labor until delivery
Duration of Labor	Time in minutes or hours from epidural bolus administration to birth.	From initiation of analgesia to delivery
Neonatal Apgar Scores	Neonatal Apgar scores assessed at 1 and 5 minutes postpartum.	At 1 minute and 5 minutes after birth
Maternal Satisfaction Score	Patient satisfaction with labor analgesia measured on a 0-10 Likert scale.	Immediately after delivery

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

General Publications

• Pazur I, Ozegic O, Lijovic L, Jaic KK, Pesic M. The Efficacy of Dural Puncture Epidural Performed by 27-gauge Whitacre Needle in Labour Epidural Analgesia: Randomized Single-Blinded Controlled Study. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):304-310. doi: 10.4274/TJAR.2023.221085.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Actual): April 3, 2026
• Study Completion (Actual): April 6, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Labor Analgesia; Dural Puncture Epidural; Standard Epidural Analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain; Agnosia
• Other Study ID Numbers: 423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request. Data will be provided via email after review and approval of the research proposal by the principal investigator.
• IPD Sharing Time Frame: IPD will be available starting 6 months after publication of the study results and will remain available for up to 5 years.

IPD Sharing Access Criteria

De-identified IPD will be shared via email upon reasonable request and PI approval.

e-mail:mehmetbaran1492@gmail.com

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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