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

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status: Enrolling

Conditions: Labor Pain; Pregnancy Related; Analgesia, Epidural

Treatments: Procedure: Dural Puncture Epidural (DPE); Procedure: Standard Epidural Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07278895

423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Dural Puncture Epidural (DPE)

Experimental group

Description:

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.

Treatment:

Procedure: Dural Puncture Epidural (DPE)

Standard Epidural Analgesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Epidural Analgesia