Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Chronic Postsurgical Pain

In brief

The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine).

Key facts

Study ID

NCT05037123

Run by

NYU Langone Health

People needed

765

Starts

2022-01-04

Expected to finish

2026-08-31

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas — Little Rock, Arkansas, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Brigham and Women's Hospital - Harvard University — Chestnut Hill, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University at St. Louis Medical Center — St Louis, Missouri, United States
• NYU Langone Health (Tisch Hospital, Kimmel Pavilion) — New York, New York, United States
• New York Presbyterian Columbia University Irving Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Montefiore Medical Center - Albert Einstein College of Medicine — The Bronx, New York, United States
• University of Pittsburgh - Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
• University of Texas - Southwestern Medical Center — Dallas, Texas, United States
• University of Texas - MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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