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Could a belly pain pump replace narcotics after hysterectomy?

NCT ID NCT04130464

Symptom relief Sponsor: Ying Liu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a continuous pump delivering numbing medicine into the belly can reduce pain and the need for narcotics after minimally invasive hysterectomy. About 120 women having surgery for non-cancer reasons will be randomly assigned to receive either a numbing drug, a numbing drug plus an anti-inflammatory, or a placebo for 72 hours after surgery. Researchers will measure pain levels and total painkiller use over three days.

What this could mean

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

Active substance
ropivacaine and ketorolac
What this could lead to
If it works, this could offer a better way to manage pain after hysterectomy and reduce the need for strong narcotics.
What could go wrong
This is a Phase 4 trial with 120 participants, so results may not apply to everyone. The pain pump itself could cause discomfort or infection.

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

About 120 people

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

Started

Sep 2019

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 65 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: * Hysterectomy planned for a benign gynecologic reason (no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain.) * Patient is scheduled to have surgery with a fellowship trained minimally invasive gynecologic surgeons at one of the study sites. * Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH). * Patient is capable of informed consent. * Patient is capable of completing the questionnaires. Exclusion Criteria: * Concern for malignancy * The procedure is scheduled outside MIGS department. * Allergy to any study related medication (i.e. Ketorolac and Ropivacaine) * Patient is enrolled in another pain management study.

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Conditions

The condition(s) this trial relates to.

opiate dependence Pain, Postoperative

As listed by the trial registrant

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

Gynecologic surgical procedures Hysterectomy Narcotic use Pain, postoperative

How to take part

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

  1. The places running it

    2 sites. 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

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • The GW Medical Faculty Associates

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

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