KALPAS

Welcome to KALPAS

KALPAS is a nationwide study of how to better manage chronic pain after mastectomy. We will study the effectiveness of a drug called ketamine to prevent post-mastectomy pain syndrome.

Who Can Participate?

  • Women, age 18 and older, who are scheduled for mastectomy due to a cancer diagnosis or as a preventative measure
  • Mastectomy can be:
    • Unilateral or Bilateral
    • +/-  lymph node dissection
    • +/- Immediate or delayed reconstruction
    • No distant metastases

Exploring ways to better manage pain after mastectomy

 

What is Mastectomy?

A mastectomy is surgery to remove a breast or part of a breast. It is usually done to treat breast cancer, but is sometimes done to prevent breast cancer in high-risk patients. Types of mastectomy include

  • Total (simple) mastectomy - removal of breast tissue and nipple
  • Modified radical mastectomy - removal of the breast, most of the lymph nodes under the arm, and often the lining over the chest muscles

What is Ketamine?

Ketamine is an FDA-approved drug used for anesthesia and for pain after surgery as well as in emergency settings. Additionally, ketamine has been used to improve mood and reduce anxiety symptoms after surgery. Also, it is used as a drug for pain that is not well controlled by opioids.

About Post-Mastectomy Pain Syndrome (PMPS)

Chronic pain affects 1 in 3 US adults, and treatment with opioids contributes significantly to the current opioid crisis. Approximately 20% of postoperative patients develop chronic postsurgical pain (CPSP), defined as pain related to surgery lasting greater than 3 months, making it one of the most common forms of chronic pain.1-3

Mastectomies are commonly performed in the US and have a particularly strong association with CPSP, where 25%-60% of patients continue to experience pain more than 3 months after surgery.5-12 Post-mastectomy pain syndrome (PMPS) may be caused by damage to peripheral nerves and/or tissues.5

  1. Macrae, W.A. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008; 101, 77-86.
  2. Werner, M.U. & Kongsgaard, U.E. I. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014; 113, 1-4.
  3. Kehlet, H., Jensen, T.S. & Woolf, C.J. Persistent postsurgical pain: risk factors and prevention. Lancet 367, 1618-1625 (2006).
  4. Gewandter, J.S., et al. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. Pain 155, 1683-1695 (2014).
  5. Meretoja, T.J., Leidenius, M.H.K., Tasmuth, T., Sipila, R. & Kalso, E. Pain at 12 months after surgery for breast cancer. JAMA 311, 90-92 (2014).