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Ketamine may ease chronic pain after mastectomy, major trial underway

NCT ID NCT05037123

Symptom relief Sponsor: NYU Langone Health 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving the drug ketamine during or right after mastectomy surgery can lower the chance of developing long-lasting pain. About 765 women having breast cancer surgery will be randomly assigned to receive a low-dose ketamine drip during surgery, a single ketamine shot after surgery, or a placebo (salt water). The goal is to see if either ketamine approach reduces pain severity and interference with daily life three months later.

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

765 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Aug 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

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: * Woman 18 years of age or older * Undergoing elective breast surgery for oncologic indication as follows: unilateral or bilateral mastectomy, prophylacticmastectomy, +/- lymph node dissection, +/- immediate or delayed reconstruction. * No distant metastases Exclusion Criteria: * History of cognitive impairment or clinical signs of altered mental status (AMS) that may interfere with adherence to study procedures and/or participant safety. Clinical signs of AMS may include but are not limited to: confusion, amnesia, disorientation, fluctuating levels of alertness, etc. * Past ketamine or phencyclidine misuse or abuse * Schizophrenia or history of psychosis * History of post-traumatic stress disorder * Known sensitivity or allergy to ketamine * Liver or renal insufficiency * History of uncontrolled hypertension, chest pain, cardiac arrhythmia, stroke, head trauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroid disease, or other contraindication to ketamine * Lamotrigine, alfentanil, physostigmine, or 4-aminopyridine use * Currently Pregnant * Body mass index (BMI) equal to or greater than 41 * Non-English or non-Spanish speaker * Currently participating in another pain interventional trial * Unwilling to comply with all study procedures and be available for the duration of the study * Patient is American Society of Anesthesiologists (ASA) physical status 4, 5, or 6 * Patient has started or undergone hormone therapy for gender transition into male. * Patient scheduled for any bilateral (or greater) flap reconstruction

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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

Chronic postsurgical pain

Contacts and locations

Locations

  • Brigham and Women's Hospital - Harvard University

    Chestnut Hill, Massachusetts, 02467, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Montefiore Medical Center - Albert Einstein College of Medicine

    The Bronx, New York, 10467, United States

  • NYU Langone Health (Tisch Hospital, Kimmel Pavilion)

    New York, New York, 10016, United States

  • New York Presbyterian Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Arkansas

    Little Rock, Arkansas, 72205, United States

  • University of Pittsburgh - Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Texas - Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Washington University at St. Louis Medical Center

    St Louis, Missouri, 63110, United States

More trials for these conditions

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