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Needle size showdown: could a tiny change improve epidural pain relief in labor?

NCT ID NCT07708909

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This trial tests whether a dural puncture epidural (a small intentional hole in the spinal membrane) using a 25-gauge or 27-gauge needle provides better pain relief during labor than a standard epidural. 240 first-time mothers in active labor will be randomly assigned to one of three techniques. The study measures pain scores throughout labor to see which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dural puncture epidural technique using a 25G or 27G spinal needle, compared with conventional epidural
What this could lead to
If successful, this could show that a specific needle size improves pain relief during labor without extra drugs.
What could go wrong
This is a small, early-stage comparison; results may not apply to all women or settings, and any epidural carries rare risks like headache or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * nulliparous women * between the 36th and 42nd gestational week * active labor and with a cervical dilation ≤ 5 cm Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

Labor Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dural puncture epidural technique Labor pain

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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