Prevention of Post Mastectomy With Intraoperative Ketamine
CompletedEarly phase 1NCT03090776
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prevention of Post-Mastectomy Pain With Perioperative Ketamine Administration: A Randomized, Placebo-controlled Trial
- Conditions
- Pain, Postoperative
- Post-Mastectomy Chronic Pain Syndrome
- Interventions
- Drug: Ketamine
- Other: Placebo saline
- Sponsor
- Brigham and Women's Hospital
- Collaborators
- National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS)
- Start date
- 2017-07-01
- Primary completion
- 2025-09-01
- Sex
- Female
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03090776