New NIH HEAL Initative Pain Management Randomized Trial

Image
Image Credit
NIH

Chronic pain contributes significantly to the current opioid epidemic. Up to 20% of postoperative patients develop chronic postsurgical pain (CPSP). CPSP is highly associated with chronic opioid use and dependence, and yet routine multi-modal analgesia as a combination of acetaminophen, NSAIDs, and anti-neuropathic agents is only moderately effective in preventing CPSP. The incidence for CPSP is particularly high in patients undergoing mastectomy (25-60%). This specific postsurgical pain condition is known as post-mastectomy pain syndrome (PMPS), and a recent study showed that one in ten patients continue to use opioids three months after surgery. NYU Langone Health will lead a multi-site clinical trial to study the effectiveness of perioperative ketamine for the prevention of PMPS. This project is funded through the NIH Helping to End Addiction Long-term (HEAL) Initiative and was a direct result of the collaborations formed in the NYU CTSI’s Pain Management Science Interest Group (now called Translational Collaborative Workgroups). Led by Drs. Jing Wang and Lisa Doan from the Department of Anesthesiology, Perioperative Care and Pain Medicine, this three-arm randomized controlled trial will aim to study the effectiveness of adding perioperative continuous or single-bolus ketamine to routine perioperative care for the prevention of PMPS. Ketamine is commonly used as a powerful analgesic for acute pain, including postoperative pain. It has also recently emerged as a mood-stabilizing agent that provides antidepressant effects lasting several weeks. Since acute pain and depressed mood are major risk factors for developing PMPS, it is hypothesized that perioperative use of ketamine could reduce the severity of PMPS. Pain, function, and mood will be assessed over twelve months after surgery. Precision models will analyze clinical variables associated with PMPS and with success of ketamine treatment. Other members of the investigative team from NYULH are Dr. Deborah Axelrod, Professor in the Department of Surgery, Dr. John Rotrosen, Professor in the Department of Psychiatry, and Dr. Binhuan Wang, Assistant Professor in the Department of Population Health.

CTSA Program In Action Goals
Goal 2: Engage Patients and Communities in Every Phase of the Translational Process
Goal 4: Innovate Processes to Increase the Quality and Efficiency of Translational Research, Particularly of Multisite Trials