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
Sponsor study identifier
interventional
165
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2026
Actual (reported)October 27, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
From t0 up to 20 minutes
Incidence of hypotension
From t0 to 50 minutes
Intraoperative ephedrine requirement
From t0 to end of surgery (assessed up to 50 minutes)
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.
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.
Epidural catheter placed with an 18G epidural needle without dural puncture; anesthesia established with the study epidural drug mixture.
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.
Ankara City Hospital Bilkent
Ankara, 06800, Turkey (Türkiye)
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.
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.
Havva Esra Uyar Türkyılmaz, Associate Professor
Ankara City Hospital Bilkent
First Submitted
October 14, 2026
First Posted
October 27, 2026
Study Start
November 1, 2026
EstimatedThe Effect of Presence of Father in the Operating Room on Quality of Recovery of the Parturient
Need for additional epidural local anesthetic
From t0 to end of surgery (assessed up to 50 minutes)
Motor block intensity
From t0 to 50 minutes
Motor block recovery time
Postoperative, up to 24 hours
Same as DPE 27G, using a 26G spinal needle for dural puncture. Same epidural drug regimen.
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.
Contact the study team to confirm eligibility.
Chau 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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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