Prevention of Post Mastectomy With Intraoperative Ketamine
Status:
Recruiting
Trial end date:
2021-11-03
Target enrollment:
Participant gender:
Summary
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
National Institute of General Medical Sciences (NIGMS) National Institutes of Health (NIH)