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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suzetrigine, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Opioid Consumption, Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Drug Suzetrigine
In addition to standard postoperative analgesia care (per surgeon), the participant in the intervention arm will receive a 14-day dosing regimen for suzetrigine. - Drug Standard Care (in control arm)
participants will receive the standard postoperative analgesia care provided by their surgeon.
Primary outcome measures
- Total Opioid Consumption Over 14 Days Postoperatively [Time frame: From enrollment to 14 days postoperatively]
Secondary outcome measures (4)
- Opioid Consumption Over Last 7 Days [Time frame: From enrollment to 3 months after surgery.]
- Incidence of Persistent Opioid Use (POU) [Time frame: From enrollment to 3 months after surgery.]
- Average, Worst, and Best Pain Over Last 7 Days [Time frame: From enrollment to 3 months after surgery.]
- opioid-related side effects [Time frame: 1 week, 14 days, 1 month, and 3 months after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Diego — La Jolla
Publications
- Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870. PMID 37530822
- McCoun J, Winkle P, Solanki D, Urban J, Bertoch T, Oswald J, Swisher MW, Taber LA, Healey T, Jazic I, Correll DJ, Negulescu PA, Bozic C, Weiner SG; VX-548-107 Study Team. Suzetrigine, a Non-Opioid NaV1.8 Inhibitor With Broad Applicability for Moderate-to-Severe Acute Pain: A Phase 3 Single-Arm Study for Surgical or Non-Surgical Acute Pain. J Pain Res. 2025 Mar 25;18:1569-1576. doi: 10.2147/JPR.S50 PMID 40165940
- Bertoch T, D'Aunno D, McCoun J, Solanki D, Taber L, Urban J, Oswald J, Swisher MW, Tian S, Miao X, Correll DJ, Negulescu P, Bozic C, Weiner SG. Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of Moderate-to-severe Acute Pain: Two Phase 3 Randomized Clinical Trials. Anesthesiology. 2025 Jun 1;142(6):1085-1099. doi: 10.1097/ALN.0000000000005460. Epub 2025 Mar 21. PMID 40117446
Identifiers
NCT: NCT07672015 · 814697