This phase IV trial studies the effects of ketamine given after surgery in improving pain in patients who undergo mastectomy surgery. Ketamine is a Food and Drug Administration (FDA)-approved, non-opioid drug. Ketamine is commonly used as a general anesthetic (medication that helps you sleep during surgery) and at low-doses, is used as an analgesic (medication that helps reduce pain). Recently, ketamine has also been FDA-approved as a treatment for depression. Giving ketamine may improve postoperative pain, sleep, mood, and postoperative recovery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04831736.
PRIMARY OBJECTIVE:
I. To examine the effect of a sub anesthetic dose of (0.6 mg/kg) of ketamine versus (vs.) saline control on postoperative pain in subjects who have undergone mastectomy.
SECONDARY OBJECTIVES:
I. To examine the effects of a sub anesthetic dose of (0.6 mg/kg) of ketamine vs. saline control on pain interference, mood, recovery (sleep quality and physical function).
II. To examine opioid use in patients who have undergone mastectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ketamine intravenously (IV) over 30 minutes on postoperative day (POD) 0. Patients also complete questionnaires at baseline, 1, 2, and 7 days post-surgery. Patients' medical records are reviewed.
ARM II: Patients receive placebo IV over 30 minutes on POD 0. Patients also complete questionnaires at baseline, 1, 2, and 7 days post-surgery. Patients' medical records are reviewed.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorLisa V. Doan
