Recruiting

Suzetrigine

Sponsor:

UCLA

Code:

NCT07672015

Conditions

Opioid Consumption, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Suzetrigine

Standard Care (in control arm)

Study Details

Brief summary:

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.

Conditions

Opioid Consumption, Postoperative

Study ID

NCT07672015

Start date

Jul 2, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

Standard Care (in control arm)

participants will receive the standard postoperative analgesia care provided by their surgeon.

Primary outcome measure

  • Total Opioid Consumption Over 14 Days Postoperatively [ Time Frame: From enrollment to 14 days postoperatively ]

Central Contacts and Locations

Central contacts

Rodney A Gabriel

858-663-7747ragabriel@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Rodney A Gabriel

858-663-7747ragabriel@health.ucsd.edu

Principal Investigator:

Rodney A Gabriel, MD, MAS

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Keywords

  • persistent postoperative opioid use
  • artificial intelligence
  • postoperative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-07-06.