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Can a simple injection ease Post-Birth pain?

NCT ID NCT03084549

Symptom relief Sponsor: Centre Hospitalier Departemental Vendee 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether injecting the anesthetic ropivacaine into the area of an episiotomy (a cut made during childbirth) reduces pain better than a placebo. 272 women who had an episiotomy during delivery took part. The goal was to see if this simple treatment could improve comfort in the days and weeks after birth.

What this could mean

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

Active substance
Ropivacaine (a local anesthetic)
What this could lead to
If it works, this could provide a simple, well-tolerated way to reduce pain after an episiotomy, potentially improving recovery for many women.
What could go wrong
This is a completed phase 3 trial, so results are available. However, the benefit may be modest or short-lived, and not all women may experience significant pain relief.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

272 people

The number who actually took part.

Started

Oct 2017

Finished

Nov 2020

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

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: * Major Patient (≥ 18 years) * Term ≥ 37 weeks of amenorrhea * Right medio-lateral episiotomy performed for medical need * Delivery of a single fetus in a cephalic presentation with or without instrumental extraction * Delivery under epidural anesthesia * Patient to be monitored over 6 months of study * Patient in ability to understand protocol * Patient having given consent and signed informed consent * Patient with social coverage Exclusion Criteria: * Hypersensitivity or known allergy to Ropivacaine or to other amide-linked local anesthetics or to any of the excipients * General contraindication specific to local anesthesia, irrespective of the local anesthetic used * Contraindication for Ropivacaine- Obstetric paracervical anesthesia * Hypovolemia * Weight \<50 kg * Contra-indication or refusal of the epidural * Poor understanding of the French language * Substance addiction. * Chronic pain syndrome. * Severe hepatic or renal impairment. * Acute porphyria. * Caesarean section programmed. * Tear of the 3rd degree according to the associated French classification. * Refusal to participate in the study * Patient under tutelage, curatorship, or deprived of liberty

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As listed by the trial registrant

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

Episiotomy

Contacts and locations

Locations

  • Centre Hospitalier Departemental Vendee

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Universitaire Nantes

    Nantes, 44093, France

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