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Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique

ConditionsLabor PainDural Puncture 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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

  • Conventional epidural

    Device

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

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: DPEA 27GExperimental treatment 1 intervention
Group B: DPEA 25GExperimental treatment 1 intervention
Group C: EpiduralActive comparator 1 intervention

Trial outcomes

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.

Time frame
From the beginning of analgesia to the end of labour

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: