Labor AnalgesiaDPENCT05990504
The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
A study testing ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia and ultrasound real-time guidance combined with Epidural Labor Anagesia in people with Labor Analgesia, run by Zongxun Lin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia and ultrasound real-time guidance combined with Epidural Labor Anagesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Labor Analgesia
- Being tested
- ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia, ultrasound real-time guidance combined with Epidural Labor Anagesia
- Keywords
- labor analgesia, delivery woman, neonate, Effectiveness, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound real-time guidance combined with Dural Puncture Epidural Labor AnagesiaDevice
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 AnagesiaDevice
Epidural is a traditional labor analgesia technique.
| Study group | Role | What they receive |
|---|---|---|
| Dural Puncture Epidural Group | Experimental | Dural Puncture Epidural is a new type of labor analgesia technology. Receives: Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia |
| Epidural Group | Active comparator | Epidural is a traditional labor analgesia technique. Receives: Device: ultrasound real-time guidance combined with Epidural Labor Anagesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Secondary outcomes (25)
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.
Measured: 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).
Measured: 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
Measured: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Incidence of hypertonus
defined as a single contraction lasting >2 minutes
Measured: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
Incidence of tachysystole
defined as >5 contractions per 10 minutes
Measured: 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
Measured: 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
Measured: 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).
Measured: 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）
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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）
Measured: 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
Measured: 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
Measured: 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.
Measured: At 1, 5, and 10 minutes after birth
Fetal heart rate variability
Assess fetal heart: Fetal heart rate variability (absent, minimal, moderate, marked)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: From labor onset to delivery of placenta(assessed up to 24 hours).
Maternal body temperature
Maternal body temperature (pre-analgesia and at delivery)
Measured: 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
Measured: 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)
Measured: 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])
Measured: At the time of cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zongxun Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zongxun Lin, Fujian Provincial Hospital
- Investigators
- Zongxun Lin, Master, Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990504
- Sponsor's protocol ID
- Dural Puncture Epidural
- Acronym
- DPE
- Status last verified
- Dec 2025
- First submitted
- 21 Apr 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
- ClinicalTrials.gov ID
- NCT05990504
- Acronym / sponsor ID
- DPE / Dural Puncture Epidural
- Conditions
- Labor Analgesia
- Keywords
- labor analgesia, delivery woman, neonate, Effectiveness, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zongxun LinUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dural Puncture Epidural Group | Experimental | Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor AnagesiaDural Puncture Epidural is a new type of labor analgesia technology. |
| Epidural Group | Active comparator | Device: ultrasound real-time guidance combined with Epidural Labor AnagesiaEpidural is a traditional labor analgesia technique. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound real-time guidance combined with Dural Puncture Epidural Labor AnagesiaDural 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. | Device | Dural Puncture Epidural Group |
| ultrasound real-time guidance combined with Epidural Labor AnagesiaEpidural is a traditional labor analgesia technique. | Device | Epidural Group |
Primary outcome
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.
25 secondary outcomes
Distribution of NICHD categories (I, II, III)
Time frame: 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).
Duration of individual uterine contractions
Time frame: 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).
Incidence of tachysystole
Time frame: 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).
Incidence of asymmetric block
Time frame: 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)
Time to analgesia onset
Time frame: 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).
Motor blockade assessed by the Modified Bromage Score
Time frame: 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)
Visual Analogue Scale
Time frame: 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)
Cesarean delivery rate
Time frame: At delivery
Neonatal Apgar scores
Time frame: 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).
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).
Clinician interventions
Time frame: 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).
The duration of each stage of labor
Time frame: From labor onset to delivery of placenta(assessed up to 24 hours).
Maternal body temperature
Time frame: 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)
Indications for cesarean delivery
Time frame: At the time of cesarean delivery
Anesthetic technique for cesarean delivery
Time frame: At the time of cesarean delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zongxun Lin, Master principal investigator
Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia and ultrasound real-time guidance combined with Epidural Labor Anagesia in people with Labor Analgesia, run by Zongxun Lin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of NICHD category elevation from baseline (time frame: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.