A Phase 4 interventional study of Suzetrigine and Standard Care (in control arm) in Opioid Consumption, Postoperative, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of California, San Diego · Phase 4, Interventional, and Treatment
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.
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.
Hypothesis 1: Pain and opioid consumption will be reduced in the suzetrigine group compare to control at multiple post-procedure time points, including 1 week, 14 days, 1 month, and 3 months after.
There will be up to 100 participants recruited who are considered high risk for POU and 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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Suzetrigine
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.
Drug: Standard Care (in control arm)
In addition to standard postoperative analgesia care (per surgeon), the participant in the intervention arm will receive a 14-day dosing regimen for suzetrigine.
Also known as: Journavx
participants 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)
Time frame: From enrollment to 14 days postoperatively
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).
Time frame: From enrollment to 3 months after surgery.
Incidence of Persistent Opioid Use (POU)
Incidence of POU, defined as any opioid consumption required at ≥ 3 months after surgery.
Time frame: From enrollment to 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).
Time frame: From enrollment to 3 months after surgery.
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.
Time frame: 1 week, 14 days, 1 month, and 3 months after surgery
Plan to share: Undecided — due to HIPAA regulations
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Diego