Prevention of Post Mastectomy With Intraoperative Ketamine

• Status: Recruiting
• Trial end date: 2021-11-03
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH)
• Treatments: Ketamine

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