Skip to main content
OpenTrials
Completed

NCT Number: NCT07278895

Dural Puncture Epidural vs Standard Epidural Analgesia in Labor

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia).
  • Placental abnormalities (placenta previa, placental abruption, etc.).
  • Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
  • Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
  • Morbid obesity (Body Mass Index ≥ 40 kg/m²).
  • Opioid dependence or chronic opioid use.
  • Accidental dural puncture with the epidural needle prior to randomization.
  • Multiple gestation or non-cephalic presentation (if clinically relevant to your protocol).
  • Fetal distress at the time of enrollment.
  • Patient refusal to participate.
  • Any condition deemed by the investigator to pose increased risk or interfere with study outcomes.

-

Treatment and study plan

Dural Puncture Epidural (DPE)

Procedure

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.

Standard Epidural Analgesia

Procedure

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.

Primary outcomes

  1. Time to Onset of Effective Analgesia (VAS < 3)

    Time frame: Within 30 minutes after epidural bolus

    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.

Secondary outcomes

  1. Sensory Block Level

    Time frame: Within 30 minutes after epidural bolus

    The highest dermatome level of sensory block assessed by pinprick or cold test.

  2. Motor Block Score (Bromage Score)

    Time frame: Within 30 minutes after epidural bolus

    Degree of motor block measured using the Bromage scale (0-3).

  3. Need for Additional Epidural Bolus

    Time frame: During labor until delivery

    Number of additional boluses required when VAS ≥ 4.

  4. Time to First Additional Bolus

    Time frame: From initiation of analgesia to delivery

    Total amount (mL) of local anesthetic administered during labor.

  5. Maternal Hemodynamic Changes

    Time frame: First 30 minutes after epidural bolus

    Changes in systolic/diastolic blood pressure and heart rate compared to baseline

  6. Maternal Side Effects

    Time frame: During labor until delivery

    Incidence of hypotension, nausea, vomiting, pruritus, urinary retention, or other complications.

  7. Post-Dural Puncture Headache (PDPH)

    Time frame: Day 3 and Day 7 postpartum

    Presence or absence of typical post-dural puncture headache symptoms.

  8. Fetal Heart Rate Changes

    Time frame: During labor until delivery

    Any abnormal fetal heart rate patterns following neuraxial analgesia.

  9. Duration of Labor

    Time frame: From initiation of analgesia to delivery

    Time in minutes or hours from epidural bolus administration to birth.

  10. Neonatal Apgar Scores

    Time frame: At 1 minute and 5 minutes after birth

    Neonatal Apgar scores assessed at 1 and 5 minutes postpartum.

  11. Maternal Satisfaction Score

    Time frame: Immediately after delivery

    Patient satisfaction with labor analgesia measured on a 0-10 Likert scale.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: DPE-LABOR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.