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Could a simple shot make hysteroscopy Pain-Free?

NCT ID NCT06653400

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding ketorolac (an anti-inflammatory) to the standard lidocaine numbing shot can reduce pain during office hysteroscopy, a procedure to look inside the uterus. Sixty women with abnormal bleeding will be randomly assigned to get either the combo or lidocaine alone. The main goal is to see if pain scores are lower with the combination.

What this could mean

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

Active substance
ketorolac and lidocaine
What this could lead to
If it works, this could offer a simple, low-cost way to make office hysteroscopy less painful for many women.
What could go wrong
This is a small early-phase trial, so results may not apply broadly. The added drug may not reduce pain significantly and could cause side effects like bleeding or stomach upset.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Started

Feb 2025

Expected to finish

Sep 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 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: * Patients assigned female at birth, * booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates. Exclusion Criteria: * Allergy to ketorolac or non-steroidal anti-inflammatory medications * Allergy to lidocaine * Presence of thrombocytopenia * Contraindications to lidocaine * History of gastritis or gastric ulcer * Acute renal failure or chronic renal disease * Chronic liver disease * History of bleeding diathesis * Long term narcotic use

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Conditions

The condition(s) this trial relates to.

agnosia Metrorrhagia pain agnosia

As listed by the trial registrant

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

Abnormal uterine bleeding Analgesia Paracervical block

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

    RECRUITING

    New York, New York, 10029, United States

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