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Completed

NCT Number: NCT05990504

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

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.

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Key information

Conditions

Labor Analgesia

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

About this study

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.

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) Class I or II;
  • Single healthy pregnancy;
  • Head showing first;
  • 37 to 41 weeks;
  • The labor process is active, and the cervix dilates<5cm;
  • Require epidural labor analgesia;
  • Volunteer to participate in this study and sign an informed consent form.

Exclusion criteria

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

Treatment and study plan

ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia

Device

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.

ultrasound real-time guidance combined with Epidural Labor Anagesia

Device

Epidural is a traditional labor analgesia technique.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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).

  9. 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）

  10. 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)

  11. 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.

  12. 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)

  13. 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）

  14. 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

  15. Cesarean delivery rate

    Time frame: At delivery

    Cesarean delivery rate among parturients receiving labor analgesia

  16. 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.

  17. 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)

  18. 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)

  19. 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)

  20. 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

  21. 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

  22. Maternal body temperature

    Time frame: Pre-analgesia and at delivery

    Maternal body temperature (pre-analgesia and at delivery)

  23. 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

  24. 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)

  25. 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])

Sponsors and collaborators

Lead sponsor

Zongxun Lin

Other

Registry information

Acronym: DPE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Dec 17, 2025

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.

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