200 Participants Needed

Ketamine for Post Mastectomy Pain

KS
KL
Overseen ByKristin L Schreiber, MD/PhD
Age: 18+
Sex: Female
Trial Phase: Phase < 1
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that ketamine, when used in small doses during surgery, does not cause significant side effects like hallucinations or nightmares, and its safety profile is similar to saline (a harmless saltwater solution).13678

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

KL

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

You are willing to participate in tests related to your mental and emotional well-being.
Willingness to be randomized to treatment with IV ketamine or saline during general anesthesia
Female
See 2 more

Exclusion Criteria

Scheduled for biopsy only
You have severe heart failure.
Pregnant
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preoperative Evaluation

Participants complete demographic, medical, psychosocial, and pain questionnaires during their preoperative office visit

1 day
1 visit (in-person)

Perioperative Intervention

Participants receive a bolus and continuous infusion of ketamine or placebo during surgery

Duration of surgery

Acute Postoperative Assessment

Pain and opioid consumption are assessed in the recovery area and upon discharge

1-2 days
Inpatient stay

Follow-up

Participants are monitored for persistent pain and psychosocial factors at various intervals post-surgery

2 years
Visits at 2 weeks, 3 months, 6 months, 12 months, and 24 months

Treatment Details

Interventions

  • Ketamine
  • Placebo saline
Trial Overview 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.
Participant Groups
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

Ketamine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
🇪🇺
Approved in European Union as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
🇺🇸
Approved in United States as Spravato for:
  • Treatment-resistant depression
🇪🇺
Approved in European Union as Spravato for:
  • Treatment-resistant depression
🇨🇦
Approved in Canada as Spravato for:
  • Treatment-resistant depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Findings from Research

A single preoperative dose of S-ketamine (0.5 mg/kg) did not significantly reduce the incidence of chronic postsurgical pain (CPSP) or acute postoperative pain in patients undergoing video-assisted thoracoscopic surgery (VATS).
However, S-ketamine improved sleep quality on the first postoperative day compared to the placebo, while showing no significant differences in anxiety levels or adverse effects between the two groups.
A Single Preoperative Dose of S-Ketamine Has No Beneficial Effect on Chronic Postsurgical Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgical Lung Lesion Resection: A Prospective Randomized Controlled Study.Zhou, R., Zhang, Y., Tang, S., et al.[2023]
In a study of 69 gynecological surgery patients, low dose ketamine (0.15 mg/Kg) administered preoperatively did not provide a preemptive analgesic effect, as indicated by similar pain scores at rest compared to placebo.
However, patients receiving ketamine postoperatively experienced less pain upon movement on the fifth day and required less morphine in the first 6 hours, suggesting that while preemptive use is ineffective, postoperative ketamine can still improve pain management.
[Effect of low-dose intravenous ketamine in postoperative analgesia for hysterectomy and adnexectomy].Gilabert Morell, A., Sánchez Pérez, C.[2013]

References

[Effect of perioperative multi-day low dose ketamine infusion on prevention of postmastectomy pain syndrome]. [2018]
A Single Preoperative Dose of S-Ketamine Has No Beneficial Effect on Chronic Postsurgical Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgical Lung Lesion Resection: A Prospective Randomized Controlled Study. [2023]
Preoperative small-dose ketamine has no preemptive analgesic effect in patients undergoing total mastectomy. [2019]
Effect of Pretreatment of S-Ketamine On Postoperative Depression for Breast Cancer Patients. [2022]
Comparison of pregabalin versus ketamine in postoperative pain management in breast cancer surgery. [2020]
[Effect of low-dose intravenous ketamine in postoperative analgesia for hysterectomy and adnexectomy]. [2013]
The post-operative analgesic effects of ketamine after canine ovariohysterectomy--a comparison between pre- or post-operative administration. [2022]
Effects of S-ketamine on Postoperative Recovery Quality and Inflammatory Response in Patients Undergoing Modified Radical Mastectomy. [2023]
The effect of low-dose ketamine on postoperative quality of recovery in patients undergoing breast cancer surgery: A randomised, placebo-controlled trial. [2021]
S-Ketamine attenuates inflammatory effect and modulates the immune response in patients undergoing modified radical mastectomy: A prospective randomized controlled trial. [2023]
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