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Morphine in spinal epidural may reduce breakthrough labor pain

NCT ID NCT06572241

Symptom relief Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a small dose of morphine to the spinal part of a combined spinal-epidural injection can reduce sudden pain during labor. Researchers will compare morphine to a placebo in 182 first-time mothers. The goal is to see if morphine helps prevent breakthrough pain and improves overall comfort.

What this could mean

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

Active substance
morphine
What this could lead to
If it works, this could provide better pain relief during labor with fewer episodes of breakthrough pain.
What could go wrong
This is a small, early-stage trial. The addition of morphine may not significantly reduce pain and could have side effects like itching or nausea.

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 182 people

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

Started

Nov 2024

Expected to finish

Dec 2026

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

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adult (≥18 years) term primiparous (≥37 weeks) patients with live singleton pregnancy * Patients who request labour analgesia and do not have any contraindications for neuraxial analgesia. * Less than or equal to 6 cm cervical dilation during the last vaginal examination. Exclusion Criteria: * Patients who are expected to be discharged within 24 hours of delivery. * Patients with chronic pain conditions, opioid use disorder, pre-gestational diabetes, obstructive sleep apnea, morbid obesity (BMI \>40 kg/m2), or fetal abnormalities. * Patients who have intramuscular morphine within 12 hours or fentanyl \>200 mcg in the preceding 4 hours. * Participants will be excluded from further analysis in case of spinal analgesic failure * Participants will be excluded from further analysis if labour lasts less than 2 hours

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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.

Labor pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G1X5, Canada

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