Pregnancy RelatedDPE-LABORNCT07278895
Dural Puncture Epidural vs Standard Epidural Analgesia in Labor
A study testing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in people with Pregnancy Related and Analgesia, Epidural, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Related, Analgesia, Epidural, Labor Pain
- What is being tested?
- Dural Puncture Epidural (DPE) and Standard Epidural Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2026to 6 Apr 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term pregnant women (≥37 weeks of gestation).
- Requesting neuraxial labor analgesia.
- Age between 18 and 45 years.
- ASA physical status I-II.
- Cervical dilation ≥ 4 cm at the time of enrollment.
- Cervical effacement ≥ 50-60%.
- Baseline pain score of VAS ≥ 3.
- Ability to provide informed consent.
Who cannot join
- Hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia).
- Placental abnormalities (placenta previa, placental abruption, etc.).
- Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
- Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
- Morbid obesity (Body Mass Index ≥ 40 kg/m²).
- Opioid dependence or chronic opioid use.
Show all 12Show fewer
- Accidental dural puncture with the epidural needle prior to randomization.
- Multiple gestation or non-cephalic presentation (if clinically relevant to your protocol).
- Fetal distress at the time of enrollment.
- Patient refusal to participate.
- Any condition deemed by the investigator to pose increased risk or interfere with study outcomes.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Outside of the US, 21070
About this study
Official title: A Randomized Prospective Trial Comparing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia for Labor in Term Pregnant Women"
This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction.
Read the detailed description
This prospective randomized clinical trial is designed to compare the efficacy and safety of Dural Puncture Epidural (DPE) analgesia with Standard Epidural Analgesia in term laboring women requesting neuraxial analgesia. The DPE technique involves performing a dural puncture with a 27-gauge Whitacre spinal needle through the Tuohy epidural needle before catheter placement, without administering any intrathecal medication. In both groups, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered following a negative epidural test dose.
The primary objective of the study is to determine whether DPE provides a faster onset and higher quality of labor analgesia compared with the conventional epidural technique. Secondary objectives include evaluating maternal hemodynamic changes, sensory and motor block characteristics, the need for additional bolus doses, total local anesthetic consumption, maternal side effects (hypotension, nausea, vomiting, pruritus, urinary retention), post-dural puncture headache, fetal heart rate changes, Apgar scores, duration of labor, and overall patient satisfaction.
Term pregnant women aged 18-45 years with cervical dilation ≥4 cm, effacement ≥50-60%, and baseline VAS ≥3 will be included. Exclusion criteria include hypertensive disorders of pregnancy, placental abnormalities, contraindications to neuraxial anesthesia, morbid obesity (BMI ≥40), drug allergy, opioid dependence, or accidental dural puncture with the epidural needle. Eligible participants will be randomly assigned to either the DPE group or the Standard Epidural group in a 1:1 ratio. All procedures will be performed at the Gazi Yaşargil Training and Research Hospital by anesthesiologists experienced in obstetric neuraxial techniques, and data will be collected by an independent observer not involved in the block procedure.
The study aims to contribute to the growing body of evidence on optimizing labor analgesia techniques by determining whether the DPE approach leads to improved analgesic effectiveness, greater maternal comfort, and stable maternal-fetal outcomes compared with standard epidural analgesia.
- Conditions
- Pregnancy Related, Analgesia, Epidural, Labor Pain
- Being tested
- Dural Puncture Epidural (DPE), Standard Epidural Analgesia
- Keywords
- Dural Puncture Epidural, Standard Epidural Analgesia, Labor Analgesia
- Medical subject headings
- Agnosia, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural Puncture Epidural (DPE)Procedure or surgery
The Dural Puncture Epidural (DPE) technique is performed by inserting a 27-gauge Whitacre spinal needle through the Tuohy epidural needle to puncture the dura without intrathecal drug injection. After removal of the spinal needle, an epidural catheter is placed, and following a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
Standard Epidural AnalgesiaProcedure or surgery
Standard Epidural Analgesia is performed using a Tuohy needle without dural puncture. An epidural catheter is inserted into the epidural space, and after a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
| Study group | Role | What they receive |
|---|---|---|
| Dural Puncture Epidural (DPE) | Experimental | Participants receive Dural Puncture Epidural analgesia using a 27G Whitacre spinal needle inserted through the Tuohy needle before epidural catheter placement, without intrathecal drug administration. Receives: Procedure: Dural Puncture Epidural (DPE) |
| Standard Epidural Analgesia | Active comparator | Participants in this arm receive Standard Epidural Analgesia. The epidural block is performed using a Tuohy needle without dural puncture, and an epidural catheter is inserted into the epidural space. After a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered. Receives: Procedure: Standard Epidural Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of Effective Analgesia (VAS < 3)
Time in minutes from the administration of the initial epidural bolus until the patient reports a pain score of VAS < 3, indicating effective labor analgesia.
Measured: Within 30 minutes after epidural bolus
Secondary outcomes (11)
Sensory Block Level
The highest dermatome level of sensory block assessed by pinprick or cold test.
Measured: Within 30 minutes after epidural bolus
Motor Block Score (Bromage Score)
Degree of motor block measured using the Bromage scale (0-3).
Measured: Within 30 minutes after epidural bolus
Need for Additional Epidural Bolus
Number of additional boluses required when VAS ≥ 4.
Measured: During labor until delivery
Time to First Additional Bolus
Total amount (mL) of local anesthetic administered during labor.
Measured: From initiation of analgesia to delivery
Maternal Hemodynamic Changes
Changes in systolic/diastolic blood pressure and heart rate compared to baseline
Measured: First 30 minutes after epidural bolus
Maternal Side Effects
Incidence of hypotension, nausea, vomiting, pruritus, urinary retention, or other complications.
Measured: During labor until delivery
Post-Dural Puncture Headache (PDPH)
Presence or absence of typical post-dural puncture headache symptoms.
Measured: Day 3 and Day 7 postpartum
Fetal Heart Rate Changes
Any abnormal fetal heart rate patterns following neuraxial analgesia.
Measured: During labor until delivery
Duration of Labor
Time in minutes or hours from epidural bolus administration to birth.
Measured: From initiation of analgesia to delivery
Neonatal Apgar Scores
Neonatal Apgar scores assessed at 1 and 5 minutes postpartum.
Measured: At 1 minute and 5 minutes after birth
Maternal Satisfaction Score
Patient satisfaction with labor analgesia measured on a 0-10 Likert scale.
Measured: Immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start20 Jan 2026
- Primary completion3 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Model description
- This study uses a two-arm parallel assignment model in which eligible laboring women are randomized equally to receive either Dural Puncture Epidural (DPE) analgesia or Standard Epidural Analgesia. Both groups are managed and observed concurrently without crossover between interventions.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Baran, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278895
- Sponsor's protocol ID
- 423
- Acronym
- DPE-LABOR
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request. Data will be provided via email after review and approval of the research proposal by the principal investigator.
Publications
Pazur I, Ozegic O, Lijovic L, Jaic KK, Pesic M. The Efficacy of Dural Puncture Epidural Performed by 27-gauge Whitacre Needle in Labour Epidural Analgesia: Randomized Single-Blinded Controlled Study. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):304-310. doi: 10.4274/TJAR.2023.221085.
PubMed 37587657
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial Comparing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia for Labor in Term Pregnant Women"
- ClinicalTrials.gov ID
- NCT07278895
- Acronym / sponsor ID
- DPE-LABOR / 423
- Conditions
- Pregnancy Related, Analgesia, Epidural, Labor Pain
- Keywords
- Dural Puncture Epidural, Standard Epidural Analgesia, Labor Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 12 Dec 2025 (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.
This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction.
Detailed description
This prospective randomized clinical trial is designed to compare the efficacy and safety of Dural Puncture Epidural (DPE) analgesia with Standard Epidural Analgesia in term laboring women requesting neuraxial analgesia. The DPE technique involves performing a dural puncture with a 27-gauge Whitacre spinal needle through the Tuohy epidural needle before catheter placement, without administering any intrathecal medication. In both groups, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered following a negative epidural test dose.
The primary objective of the study is to determine whether DPE provides a faster onset and higher quality of labor analgesia compared with the conventional epidural technique. Secondary objectives include evaluating maternal hemodynamic changes, sensory and motor block characteristics, the need for additional bolus doses, total local anesthetic consumption, maternal side effects (hypotension, nausea, vomiting, pruritus, urinary retention), post-dural puncture headache, fetal heart rate changes, Apgar scores, duration of labor, and overall patient satisfaction.
Term pregnant women aged 18-45 years with cervical dilation ≥4 cm, effacement ≥50-60%, and baseline VAS ≥3 will be included. Exclusion criteria include hypertensive disorders of pregnancy, placental abnormalities, contraindications to neuraxial anesthesia, morbid obesity (BMI ≥40), drug allergy, opioid dependence, or accidental dural puncture with the epidural needle. Eligible participants will be randomly assigned to either the DPE group or the Standard Epidural group in a 1:1 ratio. All procedures will be performed at the Gazi Yaşargil Training and Research Hospital by anesthesiologists experienced in obstetric neuraxial techniques, and data will be collected by an independent observer not involved in the block procedure.
The study aims to contribute to the growing body of evidence on optimizing labor analgesia techniques by determining whether the DPE approach leads to improved analgesic effectiveness, greater maternal comfort, and stable maternal-fetal outcomes compared with standard epidural analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a two-arm parallel assignment model in which eligible laboring women are randomized equally to receive either Dural Puncture Epidural (DPE) analgesia or Standard Epidural Analgesia. Both groups are managed and observed concurrently without crossover between interventions.
| Arm | Type | Receives |
|---|---|---|
| Dural Puncture Epidural (DPE) | Experimental | Procedure: Dural Puncture Epidural (DPE)Participants receive Dural Puncture Epidural analgesia using a 27G Whitacre spinal needle inserted through the Tuohy needle before epidural catheter placement, without intrathecal drug administration. |
| Standard Epidural Analgesia | Active comparator | Procedure: Standard Epidural AnalgesiaParticipants in this arm receive Standard Epidural Analgesia. The epidural block is performed using a Tuohy needle without dural puncture, and an epidural catheter is inserted into the epidural space. After a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Term pregnant women (≥37 weeks of gestation).
- Requesting neuraxial labor analgesia.
- Age between 18 and 45 years.
- ASA physical status I-II.
- Cervical dilation ≥ 4 cm at the time of enrollment.
Key exclusion criteria (12 listed)
- Hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia).
- Placental abnormalities (placenta previa, placental abruption, etc.).
- Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
- Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
- Morbid obesity (Body Mass Index ≥ 40 kg/m²).
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 |
|---|---|---|
| Dural Puncture Epidural (DPE)The Dural Puncture Epidural (DPE) technique is performed by inserting a 27-gauge Whitacre spinal needle through the Tuohy epidural needle to puncture the dura without intrathecal drug injection. After removal of the spinal needle, an epidural catheter is placed, and following a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered. | Procedure or surgery | Dural Puncture Epidural (DPE) |
| Standard Epidural AnalgesiaStandard Epidural Analgesia is performed using a Tuohy needle without dural puncture. An epidural catheter is inserted into the epidural space, and after a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered. | Procedure or surgery | Standard Epidural Analgesia |
Primary outcome
Time to Onset of Effective Analgesia (VAS < 3)
Time frame: Within 30 minutes after epidural bolus
Time in minutes from the administration of the initial epidural bolus until the patient reports a pain score of VAS < 3, indicating effective labor analgesia.
11 secondary outcomes
Sensory Block Level
Time frame: Within 30 minutes after epidural bolus
Motor Block Score (Bromage Score)
Time frame: Within 30 minutes after epidural bolus
Need for Additional Epidural Bolus
Time frame: During labor until delivery
Time to First Additional Bolus
Time frame: From initiation of analgesia to delivery
Maternal Hemodynamic Changes
Time frame: First 30 minutes after epidural bolus
Maternal Side Effects
Time frame: During labor until delivery
Post-Dural Puncture Headache (PDPH)
Time frame: Day 3 and Day 7 postpartum
Fetal Heart Rate Changes
Time frame: During labor until delivery
Duration of Labor
Time frame: From initiation of analgesia to delivery
Neonatal Apgar Scores
Time frame: At 1 minute and 5 minutes after birth
Maternal Satisfaction Score
Time frame: Immediately after 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 7 Apr 2026.
- Background: PubMed 37587657Pazur I, Ozegic O, Lijovic L, Jaic KK, Pesic M. The Efficacy of Dural Puncture Epidural Performed by 27-gauge Whitacre Needle in Labour Epidural Analgesia: Randomized Single-Blinded Controlled Study. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):304-310. doi: 10.4274/TJAR.2023.221085.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request. Data will be provided via email after review and approval of the research proposal by the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in people with Pregnancy Related and Analgesia, Epidural, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 8 inclusion and 12 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 7 Apr 2026. 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 Turkey (Türkiye). 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?
Time to Onset of Effective Analgesia (VAS < 3) (time frame: Within 30 minutes after epidural bolus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07278895, which also lists 1 linked publication.
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 7 Apr 2026.