The purpose of the study is to investigate the efficacy of suzetrigine for treatment of acute postoperative pain among surgical patients identified as high risk for persistent postoperative opioid use (POU). Using a validated artificial intelligence predictive model (termed SurgNet-POU) developed by the PI, electronic health record (EHR) data will be queried from all prospective surgical patients undergoing orthopedic surgery and inputted into the model to predict risk of POU (defined as requiring opioids ≥ 3 months after surgery). Those identified as high risk by the SurgNet-POU will be eligible candidates for this study. Suzetrigine (Vertex Pharmaceuticals) is an FDA-approved non-opioid oral analgesic that acts as a selective Nav1.8 sodium channel blocker. It has been shown to have efficacy in post-surgical pain and has compared favorably to placebo and similar to some opioids, without the risk of addiction or other adverse events related to opioids. Consented participants will be randomized to one of two arms: (1) standard care (termed standard care) defined as usual prescribing outpatient opioid analgesic protocols per surgical team; versus (2) standard care combined with 14-day regimen of suzetrigine. Those randomized to the suzetrigine arm will receive 100mg suzetrigine PO \~ 1-2 hours prior to surgery and take 50mg po twice a day for 14 days postoperatively. The primary outcome will be total opioid consumption over 14 days postoperatively. Secondary outcomes include average, highest and lowest pain scores at 7, 14, 30, and 90 days after surgery; and opioid consumption at 7, 30, and 90 days after surgery.
Patients who are identified as high-risk for POU as calculated by our SurgNet-POU predictive deep learning model. The probability threshold will be set at ~> 0.25. Potential participants will be screened prior to surgery by incorporating their electronic health record data in to the model.
Patients undergoing major orthopedic surgery (hip arthroplasty, knee arthroplasty, shoulder arthroplasty, joint arthroscopy, foot/ankle surgery, upper extremity fracture surgery, spine surgery), breast surgery (mastectomy, breast reconstruction), gynecological surgery (hysterectomy, myomectomy), or abdominal surgery.
Adult patients of at least 18 years of age
Has the capacity to consent
Pregnancy
Incarceration
Patients with a previous history of opioid use disorder.
Patients on fentanyl transdermal patch, methadone, and/or buprenorphine.
Parallel
Suzetrigine
DrugIn addition to standard postoperative analgesia care (per surgeon), the participant in the intervention arm will receive a 14-day dosing regimen for suzetrigine.
Standard Care (in control arm)
Drugparticipants will receive the standard postoperative analgesia care provided by their surgeon.
Total Opioid Consumption Over 14 Days Postoperatively
Primary endpoint - total opioid consumption over the first 14 postoperative days (standardized to oral morphine equivalents in milligrams)
Opioid Consumption Over Last 7 Days
Opioid consumption over last 7 days at 1 week, 1 month, and 3 months after surgery (standardized to oral oxycodone equivalents in milligrams).
Incidence of Persistent Opioid Use (POU)
Incidence of POU, defined as any opioid consumption required at ≥ 3 months after surgery.
Average, Worst, and Best Pain Over Last 7 Days
Average, worst, and best pain, measured as the 11-point Numeric Rating Scale for pain (0-10) over the last 7 days at 1 week, 14 days, 1 month, and 3 months after surgery. The lower the score on the scale corresponds to less pain and the higher the score corresponds the more pain (worse outcome).
opioid-related side effects
incidence of any opioid-related side effects over last 7 days at 1 week, 14 days, 1 month, and 3 months after surgery. These opioid-related side effects will include nausea, vomiting, sedation, and constipation.
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University of California, San Diego
Lead sponsor
Wellcome Leap Inc.
Collaborator
