Cesarean SectionNCT07897045
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
A study testing Standard Epidural Anesthesia, Dural Puncture Epidural With 27G Spinal Needle and Dural Puncture Epidural With 26G Spinal Needle in people with Cesarean Section and Anesthesia, Obstetrical, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether the dural puncture epidural (DPE) technique shortens the onset time of surgical anesthesia compared with the standard epidural technique in healthy women undergoing elective cesarean delivery, and whether the size of the spinal needle used for dural puncture… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Anesthesia, Obstetrical, Anesthesia, Epidural
- What is being tested?
- Standard Epidural Anesthesia, Dural Puncture Epidural With 27G Spinal Needle and Dural Puncture Epidural With 26G Spinal Needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 May 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women scheduled for elective cesarean delivery under epidural anesthesia
- American Society of Anesthesiologists (ASA) physical status II
- No comorbid disease
- Age 18-40 years
- Body mass index <35 kg/m²
- Term pregnancy (≥37 weeks of gestation)
- Written informed consent
Who cannot join
- Contraindications to neuraxial anesthesia (e.g., coagulopathy, local infection at the puncture site)
- Emergency cesarean delivery
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara City Hospital Bilkent
Ankara, 06800
Havva Esra Uyar Türkyılmaz, MD, 905053840429, esrauyarturkyilmaz@yahoo.com
Nihan Aydın Güzey, MD, 905056496231, nihanaydinguzey@gamil.com
About this study
Official title: Comparison of Dural Puncture Epidural Technique Using 27-Gauge and 26-Gauge Spinal Needles Versus Standard Epidural Anesthesia in Elective Cesarean Delivery: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to learn whether the dural puncture epidural (DPE) technique shortens the onset time of surgical anesthesia compared with the standard epidural technique in healthy women undergoing elective cesarean delivery, and whether the size of the spinal needle used for dural puncture (27-gauge vs 26-gauge pencil point) changes this effect.
The main question it aims to answer is: Does DPE with a 27G or 26G spinal needle reduce the time from completion of epidural drug injection to bilateral T5 sensory block compared with standard epidural anesthesia?
Read more
Researchers will also compare hypotension, ephedrine use, need for additional epidural local anesthetic, motor block, sensory block regression, and post-dural puncture headache among the three groups.
Participants will be randomly assigned to one of three groups: standard epidural, DPE with a 27G spinal needle, or DPE with a 26G spinal needle. In all groups, the same epidural drug mixture will be given through the epidural catheter, and no drug will be injected into the cerebrospinal fluid. Sensory block will be tested every minute after injection, and headache will be checked at 24 and 48 hours after surgery.
- Being tested
- Standard Epidural Anesthesia, Dural Puncture Epidural With 27G Spinal Needle, Dural Puncture Epidural With 26G Spinal Needle
- Keywords
- dural puncture epidural, epidural anesthesia, elective cesarean delivery, spinal needle gauge, post-dural puncture headache, onset time
- 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.
Standard Epidural AnesthesiaProcedure or surgery
Also called EA; conventional epidural
Epidural catheter placed with an 18G epidural needle without dural puncture; anesthesia established with the study epidural drug mixture.
Dural Puncture Epidural With 27G Spinal NeedleProcedure or surgery
Also called DPE-27
Needle-through-needle dural puncture with a 27G spinal needle via an 18G epidural needle, followed by epidural catheter placement without intrathecal drug; anesthesia established with the study epidural drug mixture.
Dural Puncture Epidural With 26G Spinal NeedleProcedure or surgery
Also called DPE-26
Needle-through-needle dural puncture with a 26G spinal needle via an 18G epidural needle, followed by epidural catheter placement without intrathecal drug; anesthesia established with the study epidural drug mixture.
| Study group | Role | What they receive |
|---|---|---|
| Standard Epidural (EA) | Active comparator | Epidural space identified at L3-4 or L4-5 with an 18G epidural needle; catheter advanced 3-4 cm; test dose 2 mL 2% lidocaine, then 7.5 mL 1% prilocaine + 7.5 mL 0.5% bupivacaine + 100 mcg fentanyl in 5 mL increments every 3 minutes. Receives: Procedure: Standard Epidural Anesthesia |
| DPE 27G | Experimental | Same as EA, but after epidural space identification the dura is punctured with a 27G spinal needle through the 18G epidural needle; CSF return is confirmed and no intrathecal drug is given before catheter placement. Same epidural drug regimen. Receives: Procedure: Dural Puncture Epidural With 27G Spinal Needle |
| DPE 26G | Experimental | Same as DPE 27G, using a 26G spinal needle for dural puncture. Same epidural drug regimen. Receives: Procedure: Dural Puncture Epidural With 26G Spinal Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of surgical anesthesia
Time (minutes) from completion of epidural drug injection (t0) to bilateral loss of pinprick sensation at the T5 dermatome, assessed every minute.
Measured: From t0 up to 20 minutes
Secondary outcomes (10)
Incidence of hypotension
Proportion of patients with systolic blood pressure <90 mmHg or >20% decrease from baseline.
Measured: From t0 to 50 minutes
Intraoperative ephedrine requirement
Total ephedrine dose (mg).
Measured: From t0 to end of surgery (assessed up to 50 minutes)
Need for additional epidural local anesthetic
Proportion of patients requiring a supplemental epidural dose and total supplemental dose (mg).
Measured: From t0 to end of surgery (assessed up to 50 minutes)
Motor block intensity
Modified Bromage score (0=no motor block, 4=complete blokck of motor limb)
Measured: From t0 to 50 minutes
Motor block recovery time
Time (minutes) from t0 to Bromage score transitions 3→2, 2→1 and 1→0.
Measured: Postoperative, up to 24 hours
Sensory block regression time
Time (minutes) from t0 to two-segment regression and regression of sensory block to T10, L1 and S2.
Measured: Postoperative, up to 24 hours
Post-dural puncture headache
Incidence and severity of postural headache (Visuel analogue score (VAS) 0-10).(VAS=0 no pain, VAS=10 unbearable pain)
Measured: 24 and 48 hours after surgery
Blood pressure
Systolic, diastolic and mean arterial pressure, in mmHg
Measured: Every minute for 15 minutes, then every 5 minutes up to 50 minutes
heart rate
the number of times heart beats per minute , pulse/min
Measured: Every minute for 15 minutes, then every 5 minutes up to 50 minutes
SpO2
the percentage of oxygen-carrying hemoglobin compared to the total hemoglobin in the blood (%)
Measured: Every minute for 15 minutes, then every 5 minutes up to 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
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 Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1:1 to standard epidural, DPE with a 27G spinal needle, or DPE with a 26G spinal needle.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Uyar Türkyılmaz, Ankara City Hospital Bilkent
- Investigators
- Havva Esra Uyar Türkyılmaz, Associate Professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897045
- Sponsor's protocol ID
- DPE-26G27G-2026
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharawi N, Williams M, Athar W, Martinello C, Stoner K, Taylor C, Guo N, Sultan P, Mhyre JM. Effect of Dural-Puncture Epidural vs Standard Epidural for Epidural Extension on Onset Time of Surgical Anesthesia in Elective Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326710. doi: 10.1001/jamanetworkopen.2023.26710.
PubMed 37526934Rao 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 37484190Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
PubMed 28067707
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dural Puncture Epidural Technique Using 27-Gauge and 26-Gauge Spinal Needles Versus Standard Epidural Anesthesia in Elective Cesarean Delivery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07897045
- Acronym / sponsor ID
- DPE-26G27G-2026
- Keywords
- dural puncture epidural, epidural anesthesia, elective cesarean delivery, spinal needle gauge, post-dural puncture headache, onset time
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
The goal of this clinical trial is to learn whether the dural puncture epidural (DPE) technique shortens the onset time of surgical anesthesia compared with the standard epidural technique in healthy women undergoing elective cesarean delivery, and whether the size of the spinal needle used for dural puncture (27-gauge vs 26-gauge pencil point) changes this effect.
The main question it aims to answer is: Does DPE with a 27G or 26G spinal needle reduce the time from completion of epidural drug injection to bilateral T5 sensory block compared with standard epidural anesthesia?
Researchers will also compare hypotension, ephedrine use, need for additional epidural local anesthetic, motor block, sensory block regression, and post-dural puncture headache among the three groups.
Participants will be randomly assigned to one of three groups: standard epidural, DPE with a 27G spinal needle, or DPE with a 26G spinal needle. In all groups, the same epidural drug mixture will be given through the epidural catheter, and no drug will be injected into the cerebrospinal fluid. Sensory block will be tested every minute after injection, and headache will be checked at 24 and 48 hours after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are randomized 1:1:1 to standard epidural, DPE with a 27G spinal needle, or DPE with a 26G spinal needle.
| Arm | Type | Receives |
|---|---|---|
| Standard Epidural (EA) | Active comparator | Procedure: Standard Epidural AnesthesiaEpidural space identified at L3-4 or L4-5 with an 18G epidural needle; catheter advanced 3-4 cm; test dose 2 mL 2% lidocaine, then 7.5 mL 1% prilocaine + 7.5 mL 0.5% bupivacaine + 100 mcg fentanyl in 5 mL increments every 3 minutes. |
| DPE 27G | Experimental | Procedure: Dural Puncture Epidural With 27G Spinal NeedleSame as EA, but after epidural space identification the dura is punctured with a 27G spinal needle through the 18G epidural needle; CSF return is confirmed and no intrathecal drug is given before catheter placement. Same epidural drug regimen. |
| DPE 26G | Experimental | Procedure: Dural Puncture Epidural With 26G Spinal NeedleSame as DPE 27G, using a 26G spinal needle for dural puncture. Same epidural drug regimen. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women scheduled for elective cesarean delivery under epidural anesthesia
- American Society of Anesthesiologists (ASA) physical status II
- No comorbid disease
- Age 18-40 years
- Body mass index <35 kg/m²
Key exclusion criteria (3 listed)
- Contraindications to neuraxial anesthesia (e.g., coagulopathy, local infection at the puncture site)
- Emergency cesarean delivery
- Refusal to participate
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 AnesthesiaAlso: EA; conventional epiduralEpidural catheter placed with an 18G epidural needle without dural puncture; anesthesia established with the study epidural drug mixture. | Procedure or surgery | Standard Epidural (EA) |
| Dural Puncture Epidural With 27G Spinal NeedleAlso: DPE-27Needle-through-needle dural puncture with a 27G spinal needle via an 18G epidural needle, followed by epidural catheter placement without intrathecal drug; anesthesia established with the study epidural drug mixture. | Procedure or surgery | DPE 27G |
| Dural Puncture Epidural With 26G Spinal NeedleAlso: DPE-26Needle-through-needle dural puncture with a 26G spinal needle via an 18G epidural needle, followed by epidural catheter placement without intrathecal drug; anesthesia established with the study epidural drug mixture. | Procedure or surgery | DPE 26G |
Primary outcome
Onset time of surgical anesthesia
Time frame: From t0 up to 20 minutes
Time (minutes) from completion of epidural drug injection (t0) to bilateral loss of pinprick sensation at the T5 dermatome, assessed every minute.
10 secondary outcomes
Incidence of hypotension
Time frame: From t0 to 50 minutes
Intraoperative ephedrine requirement
Time frame: From t0 to end of surgery (assessed up to 50 minutes)
Need for additional epidural local anesthetic
Time frame: From t0 to end of surgery (assessed up to 50 minutes)
Motor block intensity
Time frame: From t0 to 50 minutes
Motor block recovery time
Time frame: Postoperative, up to 24 hours
Sensory block regression time
Time frame: Postoperative, up to 24 hours
Post-dural puncture headache
Time frame: 24 and 48 hours after surgery
Blood pressure
Time frame: Every minute for 15 minutes, then every 5 minutes up to 50 minutes
heart rate
Time frame: Every minute for 15 minutes, then every 5 minutes up to 50 minutes
SpO2
Time frame: Every minute for 15 minutes, then every 5 minutes up to 50 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 37526934Sharawi N, Williams M, Athar W, Martinello C, Stoner K, Taylor C, Guo N, Sultan P, Mhyre JM. Effect of Dural-Puncture Epidural vs Standard Epidural for Epidural Extension on Onset Time of Surgical Anesthesia in Elective Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326710. doi: 10.1001/jamanetworkopen.2023.26710.
- Background: PubMed 37484190Rao 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.
- Background: PubMed 28067707Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
- 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.
Havva Esra Uyar Türkyılmaz, Associate Professor principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Epidural Anesthesia, Dural Puncture Epidural With 27G Spinal Needle and Dural Puncture Epidural With 26G Spinal Needle in people with Cesarean Section and Anesthesia, Obstetrical, run by Ankara City Hospital Bilkent 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 3 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 27 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 Havva Esra Uyar Türkyılmaz, Associate Professor (90 505 384 04 29, esrauyarturkyilmaz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time of surgical anesthesia (time frame: From t0 up to 20 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 NCT07897045, 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 27 Oct 2026.