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Can a simple injection make hysteroscopy Pain-Free?

NCT ID NCT07178379

Symptom relief Sponsor: Maimónides Biomedical Research Institute of Córdoba 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether injecting a local anesthetic (mepivacaine) into the ligaments around the cervix can reduce pain during an outpatient hysteroscopy. About 70 women who have never had a hysteroscopy will be randomly assigned to receive either the anesthetic or a placebo. The main goal is to see if the anesthetic lowers pain scores on a standard scale.

What this could mean

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

Active substance
Mepivacaine (local anesthetic)
What this could lead to
If it works, this could provide a simple, effective way to reduce pain during hysteroscopy, making the procedure more comfortable for many women.
What could go wrong
This is a small, early-stage trial. The placebo group receives a saline irrigation, not an injection, so blinding is imperfect. The results may not apply to all types of hysteroscopy.

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 70 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2025

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 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 * Age ≥ 18 years: To ensure that participants are legal adults and able to provide informed consent. * Indication for office-based diagnostic hysteroscopy: The patient must be scheduled for a diagnostic hysteroscopy, either for uterine cavity evaluation or diagnostic purposes. * Simple procedures like uterine polypectomies involving 1, 2, or more than 3 polyps or endometrial biopsy * No previous hysteroscopies Exclusion Criteria * Age \< 18 years * Known allergy to any local anesthetic * General contraindications to hysteroscopy including pregnancy (established via interview, last menstrual period, contraceptive use, or pregnancy test), active infection (e.g., pyometra or recent pelvic inflammatory disease), recent uterine perforation, etc. * Complex procedures like myomectomy with morcellator * Failure to access the uterine cavity * Anatomic conditions preventing cavity access * Excessive procedure duration or fluid use (fluid deficit \> 1000 cc) * Known uterine malformations * Waiting times exceeding 60 minutes * Use of analgesic medication prior to the procedure * Major complications related to the procedure including uterine perforation, creation of a false passage, or significant bleeding requiring interventions beyond standard care. * Incomplete delivery of informed consent or failure to complete the pre-procedure anxiety questionnaire.

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Conditions

The condition(s) this trial relates to.

agnosia

As listed by the trial registrant

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

Gynecologic procedure Local anesthesia Outpatient hysteroscopy Pain management Procedural pain relief

How to take part

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  1. 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 ↗

  2. A doctor treating you

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