Prevention of Post Mastectomy With Intraoperative Ketamine

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.

Timeline

Start

2017-07-01

Primary completion

2025-09-01

Completion

2025-09-01

Drugs

Indications