Prevention of Post Mastectomy With Intraoperative Ketamine
Sponsored by Brigham and Women's Hospital
About This Study
Aim 1: To determine the effectiveness of perioperatively administered ketamine to decrease acute and persistent postmastectomy pain (PPMP). Hypothesis 1.1: Patients undergoing partial or total mastectomy treated with a bolus and perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased postoperative pain and opioid utilization compared to those receiving saline control. Hypothesis 1.2: Patients undergoing partial or total mastectomy treated with a bolus and perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased persistent postoperative pain measured at one year after surgery. Aim 2: To determine whether there is increased power to detect therapeutic effectiveness in an interventional preventive trial, by enrichment with patients at high risk of PPMP. Hypothesis 2.1: Ketamine will have a greater analgesic and opioid sparing effect on pain scores in high-risk patients than non-high risk patients, compared to placebo. Hypothesis 2.2: Ketamine will have a greater preventive effect on pain burden scores at one year after surgery in high-risk patients than non-high risk patients, compared to placebo.
Conditions Studied
Interventions
- •Ketamine
- •Placebo saline
Eligibility
View full eligibility criteria
Inclusion criteria: * female * aged 18-85 years * scheduled for total or partial mastectomy * willingness to undergo psychophysical and psychosocial testing * willingness to participate in long-term follow-up * willingness to be randomized to treatment with IV ketamine or saline during general anesthesia. Exclusion criteria: * scheduled for biopsy only * pregnant * elevated ICP * schizophrenia or bipolar disorder * allergy to ketamine * Class III or higher heart failure