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Clinical Trial

Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique

NCT: NCT07708909 · NOT_YET_RECRUITING

NCT IDNCT07708909
StatusNOT_YET_RECRUITING
Start Date2026-08-01
Completion2027-12-31
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique?

Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique is a clinical trial registered under NCT07708909. Current status: NOT_YET_RECRUITING.

What is the status of NCT07708909?

The current status of NCT07708909 (Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique) is: NOT_YET_RECRUITING.

When did Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique start?

Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique started on 2026-08-01.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.