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Hypotension After Neuraxial AnesthesiaNCT07883733

Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality

A study testing Spinal Anesthesia, Epidural Anesthesia and Dural Puncture Epidural Anesthesia in people with Hypotension After Neuraxial Anesthesia and Cesarean Section, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to compare three regional anesthesia techniques (spinal, epidural, and dural puncture epidural anesthesia) in healthy pregnant women undergoing planned (elective) cesarean delivery. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Spinal Anesthesia, Epidural Anesthesia and Dural Puncture Epidural Anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2026to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant women aged 18 years or older
  • American Society of Anesthesiologists (ASA) physical status II (uncomplicated pregnancy without systemic disease)
  • Term pregnancy (37-40 weeks of gestation)
  • Singleton pregnancy
  • Scheduled for elective cesarean delivery
  • No contraindication to neuraxial anesthesia
  • Voluntary participation with signed written informed consent

Who cannot join

  • Local infection at the puncture site, coagulopathy (bleeding diathesis), or thrombocytopenia (platelet count < 100,000/mm3)
  • Severe scoliosis or history of major spinal surgery
  • Multiple pregnancy
  • History of preeclampsia, eclampsia, or gestational hypertension
  • Chronic systemic disease (diabetes mellitus, chronic kidney disease, or cardiac disease)
  • Body mass index (BMI) of 40 kg/m2 or higher
Show all 9Show fewer
  • Fetal distress or placental abnormalities (placenta previa, placental abruption, etc.)
  • Height less than 150 cm or more than 180 cm
  • Inability to communicate, neurological or psychiatric disease, or refusal to give consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ümmü Nur Bulut Ergün, MD contact

+905544738733

buluttummunur@gmail.com

Turkey (Türkiye)1 site
  • Bursa Yuksek Ihtisas Training and Research Hospital

    Bursa, Yıldırım

    Ummu Nur Bulut Ergun, MD, +905544738733, buluttummunur@gmail.com

    Derya Karasu, MD, Prof.

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Spinal, Epidural, and Dural Puncture Epidural Anesthesia on Maternal Hemodynamics and Block Efficacy in Cesarean Delivery: A Prospective Randomized Controlled Trial

The goal of this clinical trial is to compare three regional anesthesia techniques (spinal, epidural, and dural puncture epidural anesthesia) in healthy pregnant women undergoing planned (elective) cesarean delivery. The main questions it aims to answer are:

Which technique causes less low blood pressure (maternal hypotension) and requires less vasopressor medication during surgery? Which technique provides faster and more effective surgical anesthesia?

Read more

Spinal anesthesia works quickly but often causes a sudden drop in blood pressure, while epidural anesthesia is more stable but slower and sometimes incomplete. Dural puncture epidural is a newer technique that may combine the speed of spinal anesthesia with the stability of epidural anesthesia.

A total of 120 participants will be randomly assigned in equal numbers to one of the three groups. Researchers will compare the groups for blood pressure and heart rate changes, number of hypotension episodes, vasopressor use, time to reach adequate block (T6 level), block quality, need for additional pain medication, and side effects such as nausea, vomiting, and headache. Newborn well-being will be assessed with Apgar scores and umbilical cord blood gas analysis. Maternal and surgeon satisfaction will also be recorded.

Read the detailed description

Background: Spinal anesthesia is the most commonly used technique for cesarean delivery and provides a rapid, dense block; however, the sudden sympathetic blockade leads to maternal hypotension in up to 70-80% of cases, which may reduce uteroplacental blood flow and compromise the fetus. Conventional epidural anesthesia offers greater hemodynamic stability but has a slower onset and may result in patchy or inadequate block. The dural puncture epidural (DPE) technique, in which the dura is punctured with a spinal needle without intrathecal drug injection before epidural catheter placement, may facilitate translocation of epidural drugs into the intrathecal space, potentially combining a faster onset with hemodynamic stability. Existing studies show considerable methodological heterogeneity, and few trials have compared all three techniques simultaneously under a standardized protocol.

Design: This is a single-center, prospective, randomized controlled trial with three parallel arms. After written informed consent, 120 parturients scheduled for elective cesarean delivery will be randomized in a 1:1:1 ratio using a computer-generated sequence and sequentially numbered sealed envelopes on the morning of surgery to one of the following groups:

  • Group S (Spinal): Intrathecal 10 mg 0.5% hyperbaric bupivacaine + 10 mcg fentanyl.
  • Group E (Epidural): Epidural catheter placement followed by a test dose and 15-20 mL of local anesthetic solution (10 mL 0.5% isobaric bupivacaine + 50 mcg fentanyl + 5 mL 2% lidocaine + 4 mL normal saline).
  • Group DPE (Dural Puncture Epidural): Dural puncture with a 27G atraumatic spinal needle without intrathecal drug administration, followed by epidural catheter placement, test dose, and the same epidural solution as Group E.

In Groups E and DPE, if bilateral T6 sensory block is not achieved within 10 minutes, 5 mL of 0.25% bupivacaine will be administered every 5 minutes up to a cumulative maximum of 30 mL. Patients who fail to achieve adequate block or require conversion to general anesthesia will be excluded from the study.

All blocks will be performed by an experienced anesthesiologist not involved in data collection. All patients will receive standardized intravenous hydration.

Measurements: Baseline values will be recorded before the neuraxial block. Non-invasive blood pressure, heart rate (ECG), and SpO2 will be recorded every 3 minutes for the first 20 minutes after completion of the block and every 5 minutes thereafter until the end of surgery. Shock index (heart rate / systolic blood pressure) and diastolic shock index (heart rate / diastolic blood pressure) will be calculated. Hypotension is defined as a decrease in mean arterial pressure of more than 20% from baseline or systolic blood pressure below 90 mmHg and will be treated with intravenous ephedrine boluses; bradycardia is defined as heart rate below 50 beats/min and will be treated with atropine. Sensory block will be assessed bilaterally with pin-prick and cold tests, and motor block with the modified Bromage scale. Neonatal outcomes will be assessed with 1- and 5-minute Apgar scores and umbilical cord blood gas analysis. Maternal satisfaction, side effects, and post-dural puncture headache will be evaluated at the postoperative 24-hour visit. Patients will also be contacted by telephone on postoperative day 3 to assess post-dural puncture headache.

Sample size: Based on an expected hypotension incidence of 65% after spinal anesthesia and 30% after epidural and DPE techniques, a sample size of 34 patients per group was calculated (effect size w = 0.33, α = 0.05, power = 80%, G*Power 3.1.9.7). Allowing for a 15% dropout rate, 40 patients per group (120 in total) will be enrolled.

Statistical analysis: Data will be analyzed using SPSS v26.0. Normality will be assessed with the Shapiro-Wilk test. Normally distributed data will be presented as mean ± standard deviation, and non-normally distributed or ordinal data as median (minimum-maximum). One-way ANOVA or Kruskal-Wallis tests will be used to compare the three groups, followed by Tukey or Dunn post-hoc tests, respectively. Chi-square or Fisher's exact tests will be used for categorical variables, and repeated measures ANOVA for time-dependent hemodynamic changes. A p value < 0.05 will be considered statistically significant.

Being tested
Spinal Anesthesia, Epidural Anesthesia, Dural Puncture Epidural Anesthesia
Keywords
Dural Puncture Epidural, Spinal Anesthesia, Epidural Anesthesia, Maternal Hemodynamics, Shock Index, Vasopressor, Block Onset Time, Block Quality, Apgar Score
Medical subject headings
Post-Dural Puncture Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal AnesthesiaProcedure or surgery

    Single-shot intrathecal injection of 10 mg 0.5% hyperbaric bupivacaine plus 10 mcg fentanyl.

  • Epidural AnesthesiaProcedure or surgery

    Epidural catheter placement followed by incremental administration of local anesthetic and fentanyl through the catheter.

  • Dural Puncture Epidural AnesthesiaProcedure or surgery

    Dural puncture with a 27G spinal needle without intrathecal drug injection, followed by epidural catheter placement and administration of local anesthetic and fentanyl through the catheter.

Study groups in NCT07883733
Study groupRoleWhat they receive
Spinal AnesthesiaActive comparatorParticipants will receive spinal anesthesia with intrathecal 10 mg of 0.5% hyperbaric bupivacaine plus 10 mcg fentanyl.
Receives: Procedure: Spinal Anesthesia
Epidural AnesthesiaActive comparatorParticipants will receive epidural anesthesia. After epidural catheter placement and a test dose, 15-20 mL of local anesthetic solution (10 mL 0.5% isobaric bupivacaine + 50 mcg fentanyl + 5 mL 2% lidocaine + 4 mL normal saline) will be administered. If bilateral T6 sensory block is not achieved within 10 minutes, 5 mL of 0.25% bupivacaine will be given every 5 minutes up to a cumulative maximum of 30 mL.
Receives: Procedure: Epidural Anesthesia
Dural Puncture Epidural AnesthesiaActive comparatorParticipants will receive dural puncture epidural anesthesia. The dura will be punctured with a 27G spinal needle without intrathecal drug injection, followed by epidural catheter placement, a test dose, and the same epidural regimen as the Epidural Anesthesia arm (15-20 mL of 10 mL 0.5% isobaric bupivacaine + 50 mcg fentanyl + 5 mL 2% lidocaine + 4 mL normal saline; additional 5 mL of 0.25% bupivacaine every 5 minutes up to 30 mL if bilateral T6 block is not achieved within 10 minutes).
Receives: Procedure: Dural Puncture Epidural Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Maternal Hypotension

    Proportion of participants who develop at least one episode of hypotension, defined as a decrease in mean arterial pressure of more than 20% from baseline or systolic blood pressure below 90 mmHg. Baseline values are recorded before the neuraxial block. Blood pressure will be measured non-invasively every 3 minutes for the first 20 minutes after completion of the block and every 5 minutes thereafter until the end of surgery.

    Measured: From completion of the neuraxial block (time 0) until the end of surgery (approximately 90 minutes)

Secondary outcomes (7)
  1. Number of Hypotension Episodes

    Number of hypotension episodes per participant (count), using the same definition as the primary outcome.

    Measured: From completion of the neuraxial block until the end of surgery (approximately 90 minutes)

  2. Total Ephedrine Consumption

    Total dose of intravenous ephedrine administered to treat hypotension, in milligrams (mg).

    Measured: From completion of the neuraxial block until the end of surgery (approximately 90 minutes)

  3. Shock Index

    Ratio of heart rate to systolic blood pressure (unitless ratio).

    Measured: Baseline (before the block), every 3 minutes for the first 20 minutes after completion of the block, and every 5 minutes thereafter until the end of surgery (approximately 90 minutes)

  4. Diastolic Shock Index

    Ratio of heart rate to diastolic blood pressure (unitless ratio)

    Measured: Baseline (before the block), every 3 minutes for the first 20 minutes after completion of the block, and every 5 minutes thereafter until the end of surgery (approximately 90 minutes)

  5. Time to T6 Sensory Block

    Time from the end of local anesthetic injection to bilateral T6 sensory block, assessed by pin-prick and cold tests, in minutes.

    Measured: From completion of the neuraxial block until bilateral T6 sensory block is achieved

  6. Umbilical Cord Blood pH

    pH of umbilical cord blood measured by blood gas analysis (pH units).

    Measured: At delivery

  7. Incidence of Post-Dural Puncture Headache

    Proportion of participants with post-dural puncture headache, assessed in the hospital at postoperative 24 hours and by telephone on postoperative day 3.

    Measured: Postoperative 24 hours and postoperative day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: spinal anesthesia, epidural anesthesia, or dural puncture epidural anesthesia.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07883733
Sponsor's protocol ID
2026 - 13 / 6
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because participants did not provide consent for data sharing beyond the study team.

Publications

  • Wang SY, He Y, Zhu HJ, Han B. Dural puncture epidural technique provides better anesthesia quality in repeat cesarean delivery than epidural technique: Randomized controlled study. World J Clin Cases. 2022 Jul 16;10(20):6890-6899. doi: 10.12998/wjcc.v10.i20.6890.

    PubMed 36051113
  • Rao WY, Xu F, Dai SB, Mei Z, Chen XP, Lv CC, Liu CL, Ngan Kee W, Chen XZ. Comparison of Dural Puncture Epidural, Epidural and Combined Spinal-Epidural Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Drug Des Devel Ther. 2023 Jul 18;17:2077-2085. doi: 10.2147/DDDT.S415684. eCollection 2023.

    PubMed 37484190
  • Zhou S, Cao X, Zhou Y, Xu Z. Comparison of Surgical Anesthesia Onset Between Dural-Puncture Epidural and Standard Epidural Techniques for Emergency Cesarean Section: Protocol for a Randomized Controlled Trial. J Pain Res. 2025 May 16;18:2509-2519. doi: 10.2147/JPR.S514780. eCollection 2025.

    PubMed 40395936
  • Wu Q, Gan Y, Zhao Z, Luo C, Liu X, Wang B. The Effectiveness and Safety of Dural Puncture Epidural for Aged Patients Undergoing Orthopedic Surgery: A Randomized Controlled Trial. Clin Interv Aging. 2026 Jan 12;21:561324. doi: 10.2147/CIA.S561324. eCollection 2026.

    PubMed 41859290

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Anesthesia, Epidural Anesthesia and Dural Puncture Epidural Anesthesia in people with Hypotension After Neuraxial Anesthesia and Cesarean Section, run by Bursa Yuksek Ihtisas 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Oct 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ümmü Nur Bulut Ergün, MD (+905544738733, buluttummunur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Maternal Hypotension (time frame: From completion of the neuraxial block (time 0) until the end of surgery (approximately 90 minutes)). 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 NCT07883733, which also lists 4 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 20 Oct 2026.

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