An interventional study of Standard Epidural Anesthesia and Dural Puncture Epidural With 27G Spinal Needle in Cesarean Section, Anesthesia, Obstetrical and Anesthesia, Epidural, sponsored by Ankara City Hospital Bilkent. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
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.
129 studies on the registry are indexed under Post-Dural Puncture Headache; 26 are open to participants now.
This study's planned enrollment of 165 is above the median of 80 across 85 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Ankara City Hospital Bilkent is the lead sponsor of 439 studies on the registry; 110 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Standard Epidural Anesthesia
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.
Procedure: Dural Puncture Epidural With 27G Spinal Needle
Same as DPE 27G, using a 26G spinal needle for dural puncture. Same epidural drug regimen.
Procedure: Dural Puncture Epidural With 26G Spinal Needle
Epidural catheter placed with an 18G epidural needle without dural puncture; anesthesia established with the study epidural drug mixture.
Also known as: EA; conventional epidural
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.
Also known as: DPE-27
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.
Also known as: DPE-26
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.
Time frame: From t0 up to 20 minutes
Incidence of hypotension
Proportion of patients with systolic blood pressure \<90 mmHg or \>20% decrease from baseline.
Time frame: From t0 to 50 minutes
Intraoperative ephedrine requirement
Total ephedrine dose (mg).
Time frame: 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).
Time frame: 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)
Time frame: From t0 to 50 minutes
Motor block recovery time
Time (minutes) from t0 to Bromage score transitions 3→2, 2→1 and 1→0.
Time frame: 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.
Time frame: 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)
Time frame: 24 and 48 hours after surgery
Blood pressure
Systolic, diastolic and mean arterial pressure, in mmHg
Time frame: 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
Time frame: 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 (%)
Time frame: Every minute for 15 minutes, then every 5 minutes up to 50 minutes
Plan to share: No
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
Of 32 non-industry interventional studies with no phase under Post-Dural Puncture Headache, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's planned 5 months is below that.
Counting every sponsor, half of 33 studies reached it within 9 months; a quarter within 4 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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