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NMDA-receptor Antagonist

Ketamine for Post Mastectomy Pain

Phase < 1
Waitlist Available
Led By Kristin L Schreiber, MD/PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
Willingness to be randomized to treatment with IV ketamine or saline during general anesthesia
Must not have
Scheduled for biopsy only
Schizophrenia or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative-2 years post
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is investigating whether ketamine can help decrease postmastectomy pain. There are two hypotheses being tested. The first is that patients who receive ketamine will have less postoperative pain and need less opioids compared to those who receive a placebo. The second hypothesis is that patients who receive ketamine will have less persistent pain one year after surgery compared to those who receive a placebo. The second part of the trial is investigating whether ketamine is more effective in preventing pain in high-risk patients.

Who is the study for?
This trial is for women aged 18-85 scheduled for partial or total mastectomy, willing to participate in long-term follow-up and testing. It's not suitable for those only having a biopsy, pregnant, with elevated intracranial pressure (ICP), schizophrenia or bipolar disorder, an allergy to ketamine, or severe heart failure.
What is being tested?
The study tests if ketamine can reduce pain after mastectomy better than saline. Patients receive either ketamine or saline during surgery and are monitored for pain and opioid use post-surgery and persistent pain one year later. The focus is on whether ketamine helps more in patients at high risk of chronic post-surgery pain.
What are the potential side effects?
Ketamine may cause side effects like changes in blood pressure, unusual dreams, feeling disconnected from your body (dissociation), nausea, vomiting, rash or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 85 years old.
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You are planning to have surgery to remove all or part of your breast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative-2 years post
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative-2 years post for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
postmastectomy pain

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: unenrichedExperimental Treatment2 Interventions
all eligible women for partial or total mastectomy intervention will be ketamine or placebo saline
Group II: enriched for PPMP riskExperimental Treatment2 Interventions
women at high risk for persistent pain after partial or total mastectomy intervention will be ketamine or placebo saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,812 Previous Clinical Trials
8,161,271 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
292 Previous Clinical Trials
248,651 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,035 Total Patients Enrolled

Media Library

Ketamine (NMDA-receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03090776 — Phase < 1
Post Mastectomy Pain Syndrome Research Study Groups: unenriched, enriched for PPMP risk
Post Mastectomy Pain Syndrome Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT03090776 — Phase < 1
Ketamine (NMDA-receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03090776 — Phase < 1
~20 spots leftby Oct 2025
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