Active, Not RecruitingPhase 3ketamine
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Sponsored by NYU Langone Health
NCT ID
NCT05037123
Target Enrollment
765 participants
Start Date
2022-01-04
Est. Completion
2026-08-31
About This Study
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).
Conditions Studied
Interventions
- •Continuous ketamine infusion
- •Ketamine + Saline
- •Placebo
Eligibility
Sex:FEMALE
Age:18 Years - N/A
Healthy Volunteers:No
View full 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) 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
Study Locations (14)
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
+4 more locations