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Ketamine Clinical Trials

Prevention of Post-Mastectomy Pain With Perioperative Ketamine Administration: A Randomized, Placebo-controlled Trial

To see complete record on clinicaltrials.gov, please visit this link

Id: NCT03090776

Organisation Name: Brigham and Women's Hospital

Overal Status: Recruiting

Start Date: July 1, 2017

Last Update: September 16, 2021

Lead Sponsor: Brigham and Women's Hospital

Brief 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.

• Pain, Postoperative
• Post-Mastectomy Chronic Pain Syndrome