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Postpartum pain trial halted after just 3 women enrolled

NCT ID NCT05972681

Symptom relief Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested whether injecting bupivacaine with epinephrine into a vaginal tear after childbirth could reduce pain once the epidural wears off. Only 3 women participated before the trial was stopped early. Because of the tiny sample, no meaningful results were obtained.

What this could mean

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

Active substance
bupivacaine with epinephrine
What this could lead to
If it had worked, this could point toward a way to reduce postpartum pain after vaginal tear repair, potentially lowering opioid use and improving recovery.
What could go wrong
The trial was terminated early with only 3 participants, so no reliable conclusions can be drawn. It is unclear if the treatment is effective or safe in this setting.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3 people

The number who actually took part.

Started

Apr 2025

Finished

Oct 2025

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 years and older

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: * Healthy with a singleton pregnancy * English or Spanish speaking * Ongoing functioning epidural throughout the laceration repair * Multiparous or nulliparous * Ability to consent for themselves Exclusion Criteria: * Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage * Have multiple gestations * Complaints of non-functioning epidural * Allergic to bupivacaine and/or epinephrine * Received an epidural top-off (bolus of local anesthetic injected into the epidural catheter) \< 3 hours from the perineal repair * Experienced extreme pain at time of study consent (pain scale score \> 3 on 0-10 scale)

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As listed by the trial registrant

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

Vaginal laceration during delivery

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

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