Skip to main content
OpenTrials
Completed

NCT Number: NCT06849726

Epidural vs. Dural Puncture Epidural in Labor Analgesia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor Pain Epidural Analgesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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 criteria

  • Multiple gestations
  • Diagnosis of preeclampsia/eclampsia
  • Severe systemic disease
  • Contraindications to epidural analgesia (e.g., coagulopathy, infection at the injection site)
  • History of opioid dependence
  • Refusal to participate in the study protocol
  • Missing data in medical records for the retrospective group

Treatment and study plan

Standard Epidural Analgesia

Procedure

Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl.

Dural Puncture Epidural Analgesia

Procedure

Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by the same standardized dose of bupivacaine with fentanyl.

Primary outcomes

  1. Total Analgesic Consumption

    Time frame: From the initiation of epidural analgesia until delivery.

    Cumulative bupivacaine consumption measured in milligrams.

  2. Adequate Analgesia Achievement

    Time frame: Assessed at 15 minutes post-procedure and during hourly follow-ups until delivery.

    Proportion of participants achieving a target Numeric Rating Scale (NRS) score of less than 4

Secondary outcomes

  1. Incidence of Adverse Effects

    Time frame: Continuously monitored from the initial epidural dose until delivery.

    Recording of adverse effects including nausea, vomiting, pruritus, hypotension, and paresthesia

  2. Requirement for Supplemental Analgesia

    Time frame: From the initiation of epidural analgesia until delivery.

    Total number of supplemental boluses required during labor

  3. Maternal Satisfaction

    Time frame: Assessed in the early postpartum period.

    Documented patient satisfaction levels regarding the childbirth experience

  4. Post-Dural Puncture Headache

    Time frame: Up to 1 week postpartum.

    Incidence and severity of post-dural puncture headache in the postpartum period.

  5. Incidence and Severity of Motor Block

    Time frame: Monitored throughout the procedure until delivery.

    Occurrence and degree of motor block, evaluated by the Modified Bromage Scale.

  6. Maternal Hemodynamic and Fetal Heart Rate Variations

    Time frame: Continuously monitored throughout the procedure.

    Variation in maternal blood pressure, heart rate, and fetal heart rate changes.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Comparison of Standard Epidural and Dural Puncture Epidural Techniques in Labor Analgesia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Mar 5, 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.

Related clinical trials

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