New pain method may be just as good as epidural for surgery recovery

NCT ID NCT04117074

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if a local pain injection (liposomal bupivacaine) works as well as an epidural for pain relief after open gynecologic surgery. 106 adults participated. The goal was to see if the injection could provide similar pain control and recovery while being more cost-effective.

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

106 people

The number who actually took part.

Started

Apr 2021

Finished

Mar 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: * Individuals ≥ 18 years of age * Planned laparotomy by the gynecologic oncology service at the sponsor institution. Exclusion Criteria: * Individuals who have a contraindication to thoracic epidural analgesia * Individuals with a coagulation disorder * Individuals with an infection at the site of epidural placement * Individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions * Individuals with spinal pathology: abnormal spine anatomy, surgical fusion, or spinal column lesions * Individuals who have a contraindication to liposomal bupivacaine * Individuals with a known allergic reaction to liposomal bupivacaine * Individuals with Childs-Pugh Class B or C liver disease * Individuals who have a history of long-term opioid use for chronic pain, defined as use of opioid pain medications for ≥4 weeks prior to surgery.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.