Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

Last updated: April 10, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Continuous ketamine infusion

Ketamine + Saline

Placebo

Clinical Study ID

NCT05037123
21-00715
  • Ages > 18
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Woman 18 years of age or older

  • Undergoing elective breast surgery for oncologic indication as follows: unilateralor bilateral mastectomy, prophylacticmastectomy, +/- lymph node dissection, +/-immediate or delayed reconstruction.

  • No distant metastases

Exclusion

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, headtrauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroiddisease, 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 ofthe 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

Study Design

Total Participants: 765
Treatment Group(s): 3
Primary Treatment: Continuous ketamine infusion
Phase: 3
Study Start date:
January 04, 2022
Estimated Completion Date:
March 01, 2026

Study Description

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to study the effectiveness of ketamine in reducing PMPS. In a 3-arm, parallel-group study, approximately 750 adult women undergoing mastectomy or prophylactic mastectomy for oncologic reasons will be randomized to one of three arms. Participants in the first arm will receive continuous ketamine infusion starting after anesthetic induction (0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (with a maximum infusion of 6 hours) plus a postoperative saline dose, and continuation of 0.25 mg/kg/hr ketamine infusion for 2 hours postoperatively). Participants in the second arm will receive a dose of saline after induction, followed by a saline infusion during the surgery plus a single dose of 0.6 mg/kg of ketamine in the PACU, and 2 hours of saline infusion after surgery. The final group will serve as the control group and receive an intraoperative dose of saline, followed by saline infusion plus a postoperative saline dose and 2 hours of saline infusion after surgery. Participants will be followed at 1 and 7 days and 1, 3, 6, and 12 months after surgery.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Arkansas

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Brigham and Women's Hospital - Harvard University

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University at St. Louis Medical Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Montefiore Medical Center - Albert Einstein College of Medicine

    Bronx, New York 10467
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • NYC Health + Hospitals / Bellevue

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Health (Tisch Hospital, Kimmel Pavilion)

    New York, New York 10016
    United States

    Site Not Available

  • New York Presbyterian Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • University of Pittsburgh - Magee Women's Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Texas - Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

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