Breast Cancer Clinical Trial

Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

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).

View Eligibility Criteria

Eligibility Criteria

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) greater than 35
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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT05037123

Recruitment Status:

Recruiting

Sponsor:

NYU Langone Health

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There are 12 Locations for this study

See Locations Near You

Rush University Medical Center
Chicago Illinois, 60612, United States More Info
Asokumar Buvanendran, MD
Contact
312-942-3685
[email protected]
Asokumar Buvanendran, MD
Principal Investigator
Brigham and Women's Hospital - Harvard University
Chestnut Hill Massachusetts, 02467, United States More Info
Kristin Schreiber, MD, PhD
Contact
617-732-9463
[email protected]
Kristin Schreiber, MD, PhD
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
William Hooten, MD
Contact
507-266-9670
[email protected]
William Hooten, MD
Principal Investigator
Washington University at St. Louis Medical Center
Saint Louis Missouri, 63110, United States More Info
Simon Haroutounian, PhD, MSc
Contact
314-273-2240
[email protected]
Simon Haroutounian, PhD, MSc
Principal Investigator
Montefiore Medical Center - Albert Einstein College of Medicine
Bronx New York, 10467, United States More Info
Shamantha Reddy, MD, FASA
Contact
646-942-0519
[email protected]
Shamantha Reddy, MD, FASA
Principal Investigator
NYC Health + Hospitals / Bellevue
New York New York, 10016, United States More Info
Christopher DeNatale, MD
Contact
[email protected]
Christopher DeNatale, MD
Principal Investigator
NYU Langone Health
New York New York, 10016, United States More Info
Randy Cuevas, MPA
Contact
212-263-1538
[email protected]
Jing Wang, MD, PhD
Principal Investigator
New York Presbyterian Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Bret Taback, MD
Contact
212-342-3681
[email protected]
Bret Taback, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Joshua Mincer, MD, PhD
Contact
646-735-8059
[email protected]
Joshua Mincer, MD, PhD
Principal Investigator
University of Pittsburgh - Magee Women's Hospital
Pittsburgh Pennsylvania, 15213, United States More Info
Grace Lim, MD, MS
Contact
412-641-2179
[email protected]
Grace Lim, MD, MS
Principal Investigator
University of Texas - Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Gloria Cheng, MD
Contact
214-645-7011
[email protected]
Gloria Cheng, MD
Principal Investigator
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Juan Cata, MD
Contact
832-294-5900
[email protected]
Juan Cata, MD
Principal Investigator
University of Washington Medical Center
Seattle Washington, 98195, United States More Info
Michele Curratolo, MD, PhD
Contact
206-543-7817
[email protected]
Michele Curratolo, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT05037123

Recruitment Status:

Recruiting

Sponsor:


NYU Langone Health

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