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Precision Pain Management - A Randomized Clinical Trial Assessing the Efficacy of Suzetrigine on Postoperative Analgesia Among Surgical Patients at Higher Risk for Persistent Postoperative Opioid Use (POU)

RecruitingPhase 4Ages 18 Years - anyAllUniversity of California, San Diego
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ 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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy * Incarceration * Patients with a previous history of opioid use disorder. * Patients on fentanyl transdermal patch, methadone, and/or buprenorphine.
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What it tests

  • Suzetrigine
  • Standard Care (in control arm)
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Where

1 site
University of California, San Diego
La Jolla, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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