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Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique

NCT07708909 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-07-29

No results posted yet for this study

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

Interventions

DEVICE

Dural Puncture Epidural Analgesia 27G

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

DEVICE

Dural Puncture Epidural Analgesia 25G

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

DEVICE

Conventional epidural

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708909 on ClinicalTrials.gov