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New study aims to cut opioid use after breast removal surgery

NCT ID NCT06574022

Symptom relief Sponsor: University of Cincinnati 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two standard pain-block methods for people having a mastectomy (breast removal) due to breast cancer or high risk. One method uses a nerve block before surgery, the other during surgery. The goal is to see which approach reduces the need for opioid painkillers and improves recovery. About 100 adults will take part.

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 100 people

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

Started

Sep 2024

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 years and older

Sex

Anyone

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: * Patients who are 18 years of age or older * Patients undergoing mastectomy with or without axillary surgery, with or without reconstruction surgery at UCMC for breast cancer or high-risk of breast cancer. Patients with high-risk of breast cancer are those who have atypical/precancerous breast lesion(s), genetic mutation with increased risk of cancer (e.g., BRCA1, BRCA2 etc..) and/or a strong family history of breast cancer in the opinion of the investigator. Exclusion Criteria: * Patients undergoing only a partial mastectomy or tissue-based reconstruction. * Non-English speaking. * Patients who are pregnant. * Patients with an allergy to local anesthetics * Except: patients with allergies only to topical anesthetics may be included. * Patients with a preoperative acute or chronic pain disorder with an opioid prescription that has been prescribed within 30 days of surgery. Patients who have not filled such a prescription or who state they have not taken the medications prescribed, may be eligible on a case-by-case basis per investigator judgement. * Patients with a history of opioid use disorder. * Inability to provide informed consent. * Patients who otherwise in the opinion of the Investigator are not good candidates for participation (e.g., deemed unreliable for follow-up).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema

As listed by the trial registrant

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

Breast cancer Mastectomy; lymphedema

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

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