Epidural vs. Dural Puncture Epidural in Labor Analgesia

Last updated: March 3, 2026
Sponsor: Medipol University
Overall Status: Completed

Phase

N/A

Condition

Acute Pain

Treatment

Standard Epidural Analgesia

Dural Puncture Epidural Analgesia

Dural Puncture Epidural Analgesia

Clinical Study ID

NCT06849726
Epidural vs DP epidural
  • Ages 18-40
  • Female

Study Summary

Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I-II

  • Gestational age 37-42 weeks

  • Planned vaginal delivery

  • Request for labor analgesia during active labor with cervical dilation ≥ 3-4 cm

Exclusion

Exclusion Criteria:

  • Multiple gestations

  • Diagnosis of preeclampsia/eclampsia

  • Severe systemic disease

  • Contraindications to epidural analgesia (e.g., coagulopathy, infection at theinjection site)

  • History of opioid dependence

  • Refusal to participate in the study protocol

  • Missing data in medical records for the retrospective group

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Standard Epidural Analgesia
Phase:
Study Start date:
March 10, 2025
Estimated Completion Date:
December 20, 2025

Study Description

The maternal pain experience encompasses psychological and emotional components, highlighting the necessity for patient-centered assessment approaches. While standard epidural and combined spinal-epidural (CSE) techniques are common, they carry risks such as inadequate sacral coverage, motor block, or fetal bradycardia. The dural puncture epidural (DPE) technique aims to combine the advantages of EP and CSE while minimizing their disadvantages. By creating a dural hole, DPE facilitates the translocation of epidural medications into the subarachnoid space, aiming to accelerate the onset of analgesia and improve block quality.This single-center, historically controlled study consists of two consecutive cohorts managed before and after a change in the clinical protocol. Group 1 (retrospective control) received standard concentration epidural analgesia. Group 2 (prospective intervention) received the low-dose DPE technique. The study hypothesizes that the low-dose DPE technique provides non-inferior analgesic efficacy with significantly reduced total bupivacaine consumption and a superior side-effect profile compared to the standard high-dose EP technique. Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS < 4), maternal hemodynamic changes, incidence of adverse effects including paresthesia, and patient satisfaction

Connect with a study center

  • Medipol University

    Istanbul,
    Turkey

    Site Not Available

  • Medipol University

    Istanbul,
    Turkey (Türkiye)

    Site Not Available

  • Medipol University

    Istanbul 745044,
    Turkey (Türkiye)

    Site Not Available

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