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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dural Puncture Epidural Group | Experimental | Dural Puncture Epidural is a new type of labor analgesia technology. |
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| Epidural Group | Active Comparator | Epidural is a traditional labor analgesia technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zongxun Lin, Master | Fujian Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
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| ultrasound real-time guidance combined with Epidural Labor Anagesia | Device | Epidural is a traditional labor analgesia technique. |
|
| 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 |