Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age10+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

nulliparous women

between the 36th and 42nd gestational week

active labor and with a cervical dilation ≤ 5 cm

Disqualifiers

age < 18 years

ASA status > 2

patient's refusal

known fetal pathologies

Trial design

Treatments tested in this trial

  • Dural Puncture Epidural Analgesia 27G
  • Dural Puncture Epidural Analgesia 25G
  • Conventional epidural

Treatment groups

240 Participants
are divided into 3 treatment groups

Locations

This trial has no locations