Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique

NCT07708909 | Not Yet Recruiting

• 1 other identifier: 27774
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

DPEA (Dural Puncture Epidural Analgesia) is an alternative to the conventional epidural analgesia and technically a Combined Spinal Epidural (CSE) with omission of intrathecal drugs administration. To date, literature has proved several advantages of the DPEA techniquecompared to conventional epidural. However, these advantages are supposed to be limited to the use of 25 Gauge spinal needles. The aim of this project is to compare the quality of analgesia achieved after a DPEA technique performed with a 25 Gauge spinal needle versus a 27 Gauge spinal needle versus a conventional epidural, with a PIEB pump installed for analgesia maintenance. The Primary outcome will be the quality of analgesia, defined as the area under the curve (AUC) of the Numeric Pain Rating Scale (NPRS 100-0) ≤ 30 measured throughout labor and divided by labor duration (TWA-NPRS). 240 nulliparous women between the 36th and 42nd gestational week in active labor and with a cervical dilation ≤ 5 cm will be randomized according to a computer-generated random number sequence to receive a DPEA with a 25 Gauge spinal needle, a DPEA with a 27 Gauge spinal needle, or a conventional epidural.

Conditions

Labor Pain; Dural Puncture Epidural Technique

Outcome Measures

Primary Outcomes (1)

• Quality of analgesia

  Time-Weighted Average Area Under the Curve (TWA-AUC) of Numeric Pain Rating Scale (NPRS 100-0) during labour.

  From the beginning of analgesia to the end of labour

Study Arms (3)

DPEA 27G

EXPERIMENTAL

Patients in the DPEA 27G group will receive an intentional dural puncture with a 27 Gauge Whitacre spinal needle, using the needle-through-needle technique (the epidural space will be identified using a 18 Gauge Tuohy needle).

Device: Dural Puncture Epidural Analgesia 27G

DPEA 25G

EXPERIMENTAL

Patients in the DPEA 25G group will receive an intentional dural puncture with a 25 Gauge Whitacre spinal needle, using the needle-through-needle technique (the epidural space will be identified using a 18 Gauge Tuohy needle).

Device: Dural Puncture Epidural Analgesia 25G

Epidural

ACTIVE COMPARATOR

Patients in the Epidural group will receive a conventional epidural (the epidural space will be identified using a 18 Gauge Tuohy needle).

Device: Conventional epidural

Interventions

Dural Puncture Epidural Analgesia 27G DEVICE

Patients will receive an intentional dural puncture with a 27 Gauge Whitacre spinal needle, using the needle-through-needle technique.

DPEA 27G

Dural Puncture Epidural Analgesia 25G DEVICE

Patients will receive an intentional dural puncture with a 27 Gauge Whitacre spinal needle, using the needle-through-needle technique.

DPEA 25G

Conventional epidural DEVICE

Patients will receive a conventional epidural (the epidural space will be identified using a 18 Gauge Tuohy needle).

Epidural

Eligibility Criteria

• Age: 10 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• nulliparous women
• between the 36th and 42nd gestational week
• active labor and with a cervical dilation ≤ 5 cm

You may not qualify if:

• age \< 18 years
• ASA status \> 2
• patient's refusal
• known fetal pathologies
• contraindications to neuraxial techniques
• uterine anomalies or previous uterine surgery
• BMI ≥ 35
• twinning and fetal malpresentation (non cephalic).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (10)

• Gunaydin B, Erel S. How neuraxial labor analgesia differs by approach: dural puncture epidural as a novel option. J Anesth. 2019 Feb;33(1):125-130. doi: 10.1007/s00540-018-2564-y. Epub 2018 Oct 6.

  PMID: 30293143 RESULT

• 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.

  PMID: 28067707 RESULT

• Chau A, Tsen LC. Update on Modalities and Techniques for Labor Epidural Analgesia and Anesthesia. Adv Anesth. 2018 Dec;36(1):139-162. doi: 10.1016/j.aan.2018.07.006. Epub 2018 Sep 27. No abstract available.

  PMID: 30414635 RESULT

• Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.

  PMID: 18931227 RESULT

• Contreras F, Morales J, Bravo D, Layera S, Jara A, Riano C, Pizarro R, De La Fuente N, Aliste J, Finlayson RJ, Tran DQ. Dural puncture epidural analgesia for labor: a randomized comparison between 25-gauge and 27-gauge pencil point spinal needles. Reg Anesth Pain Med. 2019 May 22:rapm-2019-100608. doi: 10.1136/rapm-2019-100608. Online ahead of print.

  PMID: 31118278 RESULT

• Zhang B, Xu M, Pan C, Chen N, Shi L, Zhou Y, Liu T. Effect of dural puncture epidural block technique on fetal heart rate variability during labor analgesia. J Matern Fetal Neonatal Med. 2024 Dec;37(1):2370398. doi: 10.1080/14767058.2024.2370398. Epub 2024 Jun 27.

  PMID: 38937119 RESULT

• Yu H, Wang JF, Wang S, Wang Y, Tang G, Sun YE, Zeng YM, Cheng W. Double dural puncture epidural improves quality of labour analgesia without increasing adverse effects in primipara: A randomised controlled trial. Eur J Anaesthesiol. 2025 Sep 1;42(9):774-782. doi: 10.1097/EJA.0000000000002198. Epub 2025 May 21.

  PMID: 40400287 RESULT

• Frassanito L, Filetici N, Piersanti A, Vassalli F, Van De Velde M, Tsen LC, Zanfini BA, Catarci S, Ciancia M, Scorzoni M, Olivieri C, Draisci G. Sacral sensory blockade from 27-gauge pencil-point dural puncture epidural analgesia or epidural analgesia in laboring nulliparous parturients: a randomized controlled trial. Int J Obstet Anesth. 2024 Nov;60:104217. doi: 10.1016/j.ijoa.2024.104217. Epub 2024 Jun 14.

  PMID: 39024984 RESULT

• Maeda A, Villela-Franyutti D, Lumbreras-Marquez MI, Murthy A, Fields KG, Justice S, Tsen LC. Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the Effective Dose for 90% of Patients of Bupivacaine. Anesth Analg. 2024 Jun 1;138(6):1205-1214. doi: 10.1213/ANE.0000000000006691. Epub 2023 Oct 12.

  PMID: 37824436 RESULT

• Thangamuthu A, Russell IF, Purva M. Epidural failure rate using a standardised definition. Int J Obstet Anesth. 2013 Nov;22(4):310-5. doi: 10.1016/j.ijoa.2013.04.013. Epub 2013 Aug 6.

  PMID: 23932551 RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07