Labor PainNCT06849726
Epidural vs. Dural Puncture Epidural in Labor Analgesia
An observational study of Labor Pain and Epidural Analgesia, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain, Epidural Analgesia
- What is being tested?
- Standard Epidural Analgesia and Dural Puncture Epidural Analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 20 Dec 2025
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of healthy pregnant women (ASA physical status I-II) with a singleton pregnancy at 37-42 weeks of gestation, who planned a vaginal delivery and requested labor analgesia during active labor (cervical dilation ≥ 4 cm) at a single university hospital.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II
- Gestational age 37-42 weeks
- Planned vaginal delivery
- Request for labor analgesia during active labor with cervical dilation ≥ 4 cm
Who cannot join
- Multiple gestations
- Diagnosis of preeclampsia/eclampsia
- Severe systemic disease
- Contraindications to epidural analgesia (e.g., coagulopathy, infection at the injection site)
- History of opioid dependence
- Refusal to participate in the study protocol
- Missing data in medical records for the retrospective group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Standard Epidural and Dural Puncture Epidural Techniques in Labor Analgesia
Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction
Read the detailed description
The maternal pain experience encompasses psychological and emotional components, highlighting the necessity for patient-centered assessment approaches. While standard epidural and combined spinal-epidural (CSE) techniques are common, they carry risks such as inadequate sacral coverage, motor block, or fetal bradycardia. The dural puncture epidural (DPE) technique aims to combine the advantages of EP and CSE while minimizing their disadvantages. By creating a dural hole, DPE facilitates the translocation of epidural medications into the subarachnoid space, aiming to accelerate the onset of analgesia and improve block quality.This single-center, historically controlled study consists of two consecutive cohorts managed before and after a change in the clinical protocol. Group 1 (retrospective control) received standard concentration epidural analgesia. Group 2 (prospective intervention) received the low-dose DPE technique. The study hypothesizes that the low-dose DPE technique provides non-inferior analgesic efficacy with significantly reduced total bupivacaine consumption and a superior side-effect profile compared to the standard high-dose EP technique. Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS < 4), maternal hemodynamic changes, incidence of adverse effects including paresthesia, and patient satisfaction. Note on outcome reporting: serial intrapartum measurements of maternal blood pressure, maternal heart rate and fetal heart rate were not documented on the routine anesthesia monitoring forms used during the retrospective control period. The registered secondary outcome of maternal hemodynamic and fetal heart rate variation could therefore not be compared between the two cohorts. Baseline values recorded before the procedure were available for all 100 participants and are reported as baseline characteristics, together with the incidence of hypotension and of fetal bradycardia. No registered outcome has been removed from this record.
- Conditions
- Labor Pain, Epidural Analgesia
- Being tested
- Standard Epidural Analgesia, Dural Puncture Epidural Analgesia
- Keywords
- Labor Analgesia, Epidural Analgesia, Dural Puncture Epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Epidural AnalgesiaProcedure or surgery
Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl.
Dural Puncture Epidural AnalgesiaProcedure or surgery
Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by administration of a lower concentration of bupivacaine with the same dose of fentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Standard Epidural Analgesia | Patients in this retrospective control group received the standard concentration epidural analgesia. Using an 18-G Tuohy needle, the epidural space was identified and a catheter was advanced. No dural puncture was performed. A loading dose consisting of 0.125% bupivacaine (25 mg) and fentanyl (40 µg) in a total volume of 20 mL was administered via the catheter. Receives: Procedure: Standard Epidural Analgesia | |
| Dural Puncture Epidural (DPE) Analgesia | Patients in this prospective intervention group received the low-dose DPE technique. After identifying the epidural space, the dura mater was punctured using a 27-G spinal needle until the clear return of cerebrospinal fluid was visualized. No intrathecal medication was administered, the spinal needle was withdrawn, and the epidural catheter was positioned. A loading dose consisting of 0.0625% bupivacaine (12.5 mg) and fentanyl (40 µg) in a total volume of 20 mL was applied. Receives: Procedure: Dural Puncture Epidural Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Analgesic Consumption
Cumulative bupivacaine consumption measured in milligrams.
Measured: From the initiation of epidural analgesia until delivery.
Adequate Analgesia Achievement
Proportion of participants achieving a target Numeric Rating Scale (NRS) score of less than 4
Measured: Assessed at 15 minutes post-procedure and during hourly follow-ups until delivery.
Secondary outcomes (6)
Incidence of Adverse Effects
Recording of adverse effects including nausea, vomiting, pruritus, hypotension, and paresthesia
Measured: Continuously monitored from the initial epidural dose until delivery.
Requirement for Supplemental Analgesia
Total number of supplemental boluses required during labor
Measured: From the initiation of epidural analgesia until delivery.
Maternal Satisfaction
Documented patient satisfaction levels regarding the childbirth experience
Measured: Assessed in the early postpartum period.
Post-Dural Puncture Headache
Incidence and severity of post-dural puncture headache in the postpartum period.
Measured: Up to 1 week postpartum.
Incidence and Severity of Motor Block
Occurrence and degree of motor block, evaluated by the Modified Bromage Scale.
Measured: Monitored throughout the procedure until delivery.
Maternal Hemodynamic and Fetal Heart Rate Variations
Variation in maternal blood pressure, heart rate, and fetal heart rate changes.
Measured: Continuously monitored throughout the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start10 Mar 2025
- Primary completion20 Oct 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
- Investigators
- Burak öMÜR, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849726
- Sponsor's protocol ID
- Epidural vs DP epidural
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Publications
Lin W, Yang Y, Lin J, Chen J, Lin Q. Dural Puncture Epidural with 25-G Spinal Needles versus Conventional Epidural Technique in Conjunction with PIEB for Labor Analgesia: A Randomized Trial. J Pain Res. 2023 Nov 8;16:3797-3805. doi: 10.2147/JPR.S424082. eCollection 2023.
PubMed 38026464Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z. Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-978. doi: 10.1213/ANE.0000000000004768.
PubMed 32282386Wang J, Zhang L, Zheng L, Xiao P, Wang Y, Zhang L, Zhou M. A randomized trial of the dural puncture epidural technique combined with programmed intermittent epidural boluses for labor analgesia. Ann Palliat Med. 2021 Jan;10(1):404-414. doi: 10.21037/apm-20-2281.
PubMed 33545772
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Epidural and Dural Puncture Epidural Techniques in Labor Analgesia
- ClinicalTrials.gov ID
- NCT06849726
- Acronym / sponsor ID
- Epidural vs DP epidural
- Conditions
- Labor Pain, Epidural Analgesia
- Keywords
- Labor Analgesia, Epidural Analgesia, Dural Puncture Epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 27 Feb 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.
Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction
Detailed description
The maternal pain experience encompasses psychological and emotional components, highlighting the necessity for patient-centered assessment approaches. While standard epidural and combined spinal-epidural (CSE) techniques are common, they carry risks such as inadequate sacral coverage, motor block, or fetal bradycardia. The dural puncture epidural (DPE) technique aims to combine the advantages of EP and CSE while minimizing their disadvantages. By creating a dural hole, DPE facilitates the translocation of epidural medications into the subarachnoid space, aiming to accelerate the onset of analgesia and improve block quality.This single-center, historically controlled study consists of two consecutive cohorts managed before and after a change in the clinical protocol. Group 1 (retrospective control) received standard concentration epidural analgesia. Group 2 (prospective intervention) received the low-dose DPE technique. The study hypothesizes that the low-dose DPE technique provides non-inferior analgesic efficacy with significantly reduced total bupivacaine consumption and a superior side-effect profile compared to the standard high-dose EP technique. Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS < 4), maternal hemodynamic changes, incidence of adverse effects including paresthesia, and patient satisfaction. Note on outcome reporting: serial intrapartum measurements of maternal blood pressure, maternal heart rate and fetal heart rate were not documented on the routine anesthesia monitoring forms used during the retrospective control period. The registered secondary outcome of maternal hemodynamic and fetal heart rate variation could therefore not be compared between the two cohorts. Baseline values recorded before the procedure were available for all 100 participants and are reported as baseline characteristics, together with the incidence of hypotension and of fetal bradycardia. No registered outcome has been removed from this record.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Epidural Analgesia | – | Procedure: Standard Epidural AnalgesiaPatients in this retrospective control group received the standard concentration epidural analgesia. Using an 18-G Tuohy needle, the epidural space was identified and a catheter was advanced. No dural puncture was performed. A loading dose consisting of 0.125% bupivacaine (25 mg) and fentanyl (40 µg) in a total volume of 20 mL was administered via the catheter. |
| Dural Puncture Epidural (DPE) Analgesia | – | Procedure: Dural Puncture Epidural AnalgesiaPatients in this prospective intervention group received the low-dose DPE technique. After identifying the epidural space, the dura mater was punctured using a 27-G spinal needle until the clear return of cerebrospinal fluid was visualized. No intrathecal medication was administered, the spinal needle was withdrawn, and the epidural catheter was positioned. A loading dose consisting of 0.0625% bupivacaine (12.5 mg) and fentanyl (40 µg) in a total volume of 20 mL was applied. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of healthy pregnant women (ASA physical status I-II) with a singleton pregnancy at 37-42 weeks of gestation, who planned a vaginal delivery and requested labor analgesia during active labor (cervical dilation ≥ 4 cm) at a single university hospital.
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I-II
- Gestational age 37-42 weeks
- Planned vaginal delivery
- Request for labor analgesia during active labor with cervical dilation ≥ 4 cm
Key exclusion criteria (7 listed)
- Multiple gestations
- Diagnosis of preeclampsia/eclampsia
- Severe systemic disease
- Contraindications to epidural analgesia (e.g., coagulopathy, infection at the injection site)
- History of opioid dependence
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 |
|---|---|---|
| Standard Epidural AnalgesiaAdministration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl. | Procedure or surgery | Standard Epidural Analgesia |
| Dural Puncture Epidural AnalgesiaAdministration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by administration of a lower concentration of bupivacaine with the same dose of fentanyl. | Procedure or surgery | Dural Puncture Epidural (DPE) Analgesia |
Primary outcome
Total Analgesic Consumption
Time frame: From the initiation of epidural analgesia until delivery.
Cumulative bupivacaine consumption measured in milligrams.
Adequate Analgesia Achievement
Time frame: Assessed at 15 minutes post-procedure and during hourly follow-ups until delivery.
Proportion of participants achieving a target Numeric Rating Scale (NRS) score of less than 4
6 secondary outcomes
Incidence of Adverse Effects
Time frame: Continuously monitored from the initial epidural dose until delivery.
Requirement for Supplemental Analgesia
Time frame: From the initiation of epidural analgesia until delivery.
Maternal Satisfaction
Time frame: Assessed in the early postpartum period.
Post-Dural Puncture Headache
Time frame: Up to 1 week postpartum.
Incidence and Severity of Motor Block
Time frame: Monitored throughout the procedure until delivery.
Maternal Hemodynamic and Fetal Heart Rate Variations
Time frame: Continuously monitored throughout the procedure.
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 1 Sep 2026.
- Background: PubMed 38026464Lin W, Yang Y, Lin J, Chen J, Lin Q. Dural Puncture Epidural with 25-G Spinal Needles versus Conventional Epidural Technique in Conjunction with PIEB for Labor Analgesia: A Randomized Trial. J Pain Res. 2023 Nov 8;16:3797-3805. doi: 10.2147/JPR.S424082. eCollection 2023.
- Background: PubMed 32282386Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z. Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-978. doi: 10.1213/ANE.0000000000004768.
- Background: PubMed 33545772Wang J, Zhang L, Zheng L, Xiao P, Wang Y, Zhang L, Zhou M. A randomized trial of the dural puncture epidural technique combined with programmed intermittent epidural boluses for labor analgesia. Ann Palliat Med. 2021 Jan;10(1):404-414. doi: 10.21037/apm-20-2281.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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.
Burak öMÜR principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain and Epidural Analgesia, run by Medipol University 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 4 inclusion and 7 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 1 Sep 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?
Total Analgesic Consumption (time frame: From the initiation of epidural analgesia until delivery.). The study lists 2 primary outcomes in all. 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 NCT06849726, which also lists 3 linked publications.
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 1 Sep 2026.