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

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: Completed
• Conditions: Labor Analgesia
• Intervention / Treatment: Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia; Device: ultrasound real-time guidance combined with Epidural Labor Anagesia

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: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The incidence of NICHD category elevation from baseline	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

Outcome Measure	Measure Description	Time Frame
Distribution of NICHD categories (I, II, III)	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	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-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	defined as a single contraction lasting >2 minutes	From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Incidence of tachysystole	defined as >5 contractions per 10 minutes	From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Uterine contraction frequency	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	defined as a ≥2-dermatome difference between left and right sides	During the labor analgesia period (assessed up to 24 hours)
Sensory blockade level	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	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	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	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)	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-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	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	Cesarean delivery rate among parturients receiving labor analgesia	At delivery
Neonatal Apgar scores	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	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	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	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	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	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	Maternal body temperature (pre-analgesia and at delivery)	Pre-analgesia and at delivery
Side effects and complications of labor analgesia	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	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	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

• Sponsor: Zongxun Lin
• Investigators: Principal Investigator: Zongxun Lin, Master, Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Effectiveness; neonate; labor analgesia; delivery woman
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID 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