The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia (DPE)

December 10, 2025 updated by: Zongxun Lin
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal.Dural Puncture Epidural Technique improves Labor Analgesia Quality And Safety By Increasing Drug Permeation.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block. The theoretical basis is that anesthetic drugs can originally penetrate into the subarachnoid space from the epidural space through a complete spinal dura, and the puncture hole formed by spinal dura puncture facilitates this process.After injecting high volume anesthetic drugs into the epidural space, the pressure increases, and the drug penetrates from the epidural space through the puncture hole along a pressure gradient to the subarachnoid space, thereby enhancing the effect of labor analgesia.Dural Puncture Epidural also has the advantage of verifying that the epidural needle is in the middle of the epidural space again, thereby reducing the incidence of epidural catheter insertion failure or deviation to one side.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Class I or II;
  2. Single healthy pregnancy;
  3. Head showing first;
  4. 37 to 41 weeks;
  5. The labor process is active, and the cervix dilates<5cm;
  6. Require epidural labor analgesia;
  7. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

  1. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;
  2. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;
  3. Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;
  4. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.
  5. Patients with long-term use of opioids, steroids, and chronic pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dural Puncture Epidural Group
Dural Puncture Epidural is a new type of labor analgesia technology.
Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block.
Active Comparator: Epidural Group
Epidural is a traditional labor analgesia technique.
Device: ultrasound real-time guidance combined with Epidural Labor Anagesia
Epidural is a traditional labor analgesia technique.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of NICHD category elevation from baseline
Time Frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
NICHD (National Institute of Child Health and Human Development) Fetal Heart Tracing Classification: Category I (normal), Category II (indeterminate), Category III (abnormal). A higher category (e.g., III vs. I) indicates a less reassuring fetal status.
From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distribution of NICHD categories (I, II, III)
Time Frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
NICHD (National Institute of Child Health and Human Development) Fetal Heart Tracing Classification: Category I (normal), Category II (indeterminate), Category III (abnormal). A higher category (e.g., III vs. I) indicates a less reassuring fetal status.
From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Fetal heart rate
Time Frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Assess fetal heart rate(time-weighted mean derived from area under the curve calculation).
From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Duration of individual uterine contractions
Time Frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Time-weighted mean duration of individual uterine contractions, derived from area under the curve (AUC) calculation
From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Incidence of hypertonus
Time Frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
defined as a single contraction lasting >2 minutes
From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Incidence of tachysystole
Time Frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
defined as >5 contractions per 10 minutes
From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Uterine contraction frequency
Time Frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Time-weighted mean uterine contraction frequency, derived from area under the curve (AUC) calculation
From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Incidence of asymmetric block
Time Frame: During the labor analgesia period (assessed up to 24 hours)
defined as a ≥2-dermatome difference between left and right sides
During the labor analgesia period (assessed up to 24 hours)
Sensory blockade level
Time Frame: During the labor analgesia period (assessed up to 24 hours)
Sensory blockade level was assessed by loss of cold sensation using an alcohol swab. The sensory level was determined and recorded in accordance with anatomical landmarks: pubic symphysis (T12), umbilical region (T10), hypochondrium (T8), xiphoid process (T6), nipple line (T4), and subclavian region (T2).
During the labor analgesia period (assessed up to 24 hours)
Time to analgesia onset
Time Frame: Within 30 minutes after initial drug administration
The time from initial drug administration to the first documented pain Visual Analogue Scale (VAS) score ≤ 30 mm. Visual Analogue Scale（scale title=Visual Analogue Scale，Total score=0-10,0=no pain,10=worst possible pain）
Within 30 minutes after initial drug administration
Number of patient-controlled analgesia (PCA) demands
Time Frame: Through the completion of labor analgesia (assessed from initiation to delivery, up to 24 hours).
Number of patient-controlled analgesia (PCA) demands(Press the PCA button when the patient feels pain)
Through the completion of labor analgesia (assessed from initiation to delivery, up to 24 hours).
Motor blockade assessed by the Modified Bromage Score
Time Frame: During the labor analgesia period (assessed up to 24 hours)
Modified Bromage Score: 0 = full flexion of knees and ankles, 1 = partial flexion of knees, full flexion of ankles, 2 = inability to flex knees and partial flexion of ankles, and 3 = inability to flex knees and ankles.
During the labor analgesia period (assessed up to 24 hours)
Sensory blockade at the second sacral dermatome (S2)
Time Frame: During the labor analgesia period (assessed up to 24 hours)
Sensory blockade at the second sacral dermatome (S2) (bilateral, unilateral, none)
During the labor analgesia period (assessed up to 24 hours)
Visual Analogue Scale
Time Frame: Through the completion of labor analgesia (assessed from initiation to delivery, up to 24 hours).
Time-weighted mean pain Visual Analogue Scale (VAS) score, derived from area under the curve (AUC) calculation; Visual Analogue Scale（scale title=Visual Analogue Scale，Total score=0-10,0=no pain,10=worst possible pain）
Through the completion of labor analgesia (assessed from initiation to delivery, up to 24 hours).
Procedure-related complications of labor analgesia
Time Frame: From the time of the analgesia procedure until the completion of the study-specific follow-up period(assessed up to 1 week)
Accidental dural puncture with an epidural needle
From the time of the analgesia procedure until the completion of the study-specific follow-up period(assessed up to 1 week)
Cesarean delivery rate
Time Frame: At delivery
Cesarean delivery rate among parturients receiving labor analgesia
At delivery
Neonatal Apgar scores
Time Frame: At 1, 5, and 10 minutes after birth
The Apgar score is a standardized assessment of newborn viability, ranging from 0 to 10. Scores are typically interpreted as: 0-3 indicating a need for urgent resuscitation, 4-6 indicating a need for some resuscitative measures, and 7-10 generally considered reassuring. In this study, Apgar scores are assessed at 1, 5, and 10 minutes after birth.
At 1, 5, and 10 minutes after birth
Fetal heart rate variability
Time Frame: Baseline period (prior to analgesia initiation) and the analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
Assess fetal heart: Fetal heart rate variability (absent, minimal, moderate, marked)
Baseline period (prior to analgesia initiation) and the analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
Fetal Heart Rate decelerations
Time Frame: Baseline period (prior to analgesia initiation) and the analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
Assess fetal heart: Fetal heart rate decelerations (early, late, variable)
Baseline period (prior to analgesia initiation) and the analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
Clinician interventions
Time Frame: The analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
Clinician interventions (Analgesic Regimen Adjustments, Epidural Catheter Manipulations, Re-puncture)
The analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
Local anesthetic consumption
Time Frame: The analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
Per-minute local anesthetic consumption and Total local anesthetic consumption
The analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).
The duration of each stage of labor
Time Frame: From labor onset to delivery of placenta(assessed up to 24 hours).
The duration of the first, second, third, and total stages of labor
From labor onset to delivery of placenta(assessed up to 24 hours).
Maternal body temperature
Time Frame: Pre-analgesia and at delivery
Maternal body temperature (pre-analgesia and at delivery)
Pre-analgesia and at delivery
Side effects and complications of labor analgesia
Time Frame: From analgesia initiation until 72 hours after delivery (assessed up to 72 hours)
Incidence of lower limb numbness, Incidence of urinary retention, Incidence of nausea and vomiting, Incidence of postpartum headache
From analgesia initiation until 72 hours after delivery (assessed up to 72 hours)
Indications for cesarean delivery
Time Frame: At the time of cesarean delivery
Indications for cesarean delivery (non-reassuring fetal heart rate, arrest of descent, maternal indications, other)
At the time of cesarean delivery
Anesthetic technique for cesarean delivery
Time Frame: At the time of cesarean delivery
Anesthetic technique for cesarean delivery (epidural top-up, re-puncture combined spinal-epidural, general anesthesia)(Exploratory analysis added post-hoc based on reviewer feedback during the peer-review process for manuscript [Anesthesiology Research and Practice, Manuscript ID: 1197441])
At the time of cesarean delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zongxun Lin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zongxun Lin, Master, Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dural Puncture Epidural

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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