Ketamine for Post Mastectomy Pain
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is ketamine effective in reducing post-mastectomy pain?
Research shows that using low-dose ketamine over several days after breast cancer surgery can effectively reduce post-mastectomy pain and the need for additional pain medication. Patients receiving ketamine had lower pain scores and a reduced incidence of long-term pain compared to those who received a placebo.12345
Is ketamine safe for humans in clinical trials for post-mastectomy pain?
How does the drug ketamine differ from other treatments for post-mastectomy pain?
Ketamine is unique because it can be administered as a low-dose infusion over several days, which helps reduce the incidence of post-mastectomy pain syndrome and lowers the need for other pain medications. Unlike typical pain treatments, ketamine also has anti-inflammatory effects and can improve emotional recovery after surgery.135910
What is the purpose of this trial?
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.
Research Team
Kristin Schreiber, MD, PhD
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Evaluation
Participants complete demographic, medical, psychosocial, and pain questionnaires during their preoperative office visit
Perioperative Intervention
Participants receive a bolus and continuous infusion of ketamine or placebo during surgery
Acute Postoperative Assessment
Pain and opioid consumption are assessed in the recovery area and upon discharge
Follow-up
Participants are monitored for persistent pain and psychosocial factors at various intervals post-surgery
Treatment Details
Interventions
- Ketamine
- Placebo saline
Ketamine is already approved in United States, European Union, Canada for the following indications:
- Anesthesia
- Treatment-resistant depression
- Anesthesia
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of General Medical Sciences (NIGMS)
Collaborator