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)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption Over 14 Days Postoperatively
研究概览
简要总结
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.
详细描述
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.
Our objective is to investigate the therapeutic benefits of suzetrigine for postoperative analgesia among patients identified as high risk for POU from our AI model, SurgNet-POU.
Primary Specific Aim. Demonstrate the potential efficacy of suzetrigine for postoperative analgesia in patients undergoing major surgery that are identified as high risk for POU. This will be performed as a pilot study and executed as a randomized clinical trial of up to 100 participants.
Hypothesis 1: Use of suzetrigine as part of a postoperative outpatient oral regimen will reduce 14-day postoperative opioid consumption in patients that are higher risk for POU.
Secondary Specific Aim: Among patients that are identified as high risk for POU after surgery, demonstrate the potential efficacy of suzetrigine in reducing pain and POU incidence after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •Pregnancy
- •Incarceration
- •Patients with a previous history of opioid use disorder.
- •Patients on fentanyl transdermal patch, methadone, and/or buprenorphine.
研究组 & 干预措施
Suzetrigine + Standard Care (standard outpatient analgesic prescriptions per surgical team)
Suzetrigine is a selective sodium channel blocker, specifically targeting the Nav1.8 sodium channel found in peripheral pain-sensing nerves. Suzetrigine has been FDA approved for acute pain management for moderate-to-severe acute pain (e.g., post-surgical pain) and represents the first new class of pain medication in decades. Compared to opioids, there is no risk of respiratory depression, no associated euphoria (thus lower addiction risk), and does not act on the opioid receptors. Compared to NSAIDs, it has no kidney or GI bleeding risk or effects on the platelets. For participants randomized to this arm, they will receive 100mg po once preoperatively (approximately 1 - 2 hours prior to surgery) in the preoperative holding area. They will then receive 14 days 50mg po twice a day (first dose to start the evening of postoperative day 0. In addition, the participants will receive standard outpatient analgesic prescribing per their surgical provider.
干预措施: Suzetrigine (Drug)
Standard Care Alone
Participants in this group will receive standard outpatient analgesic prescribing (combination of opioids, NSAIDs, acetaminophen) per their surgical provider. No placebo pill will be administered.
干预措施: Standard Care (in control arm) (Drug)
结局指标
主要结局
Total Opioid Consumption Over 14 Days Postoperatively
时间窗: From enrollment to 14 days postoperatively
Primary endpoint - total opioid consumption over the first 14 postoperative days (standardized to oral morphine equivalents in milligrams)
次要结局
- Incidence of Persistent Opioid Use (POU)(From enrollment to 3 months after surgery.)
- Opioid Consumption Over Last 7 Days(From enrollment to 3 months after surgery.)
- Average, Worst, and Best Pain Over Last 7 Days(From enrollment to 3 months after surgery.)
- opioid-related side effects(1 week, 14 days, 1 month, and 3 months after surgery)
研究者
Rodney Gabriel
Professor
University of California, San Diego