Precision pain management plan using suzetrigine in high-risk surgical patients
Official title: 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)
Run by University of California, San Diego · NCT07672015 · Data updated 2026-11-12
In people at high risk for long-term opioid use after surgery, this trial tests whether taking suzetrigine around the time of surgery reduces overall opioid use in the first 14 days postoperatively.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Status | Recruiting |
| Started | July 2, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07672015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ undergoing specified major surgeries who are identified as high risk for persistent postoperative opioid use by the SurgNet-POU AI model (predicted risk > ~0.25).
✕Probably not a fit
Patients not at high risk for persistent opioid use or those with contraindications to suzetrigine may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, phase 4 trial enrolls adults undergoing major orthopedic, breast, gynecologic, or abdominal surgery who are identified as high risk for persistent postoperative opioid use by a validated AI model. Participants are randomized to standard care or standard care plus a 14-day suzetrigine regimen starting before surgery. Suzetrigine is a non-opioid analgesic that blocks Nav1.8 sodium channels and has shown analgesic effects with an opioid-sparing profile in prior studies. The primary outcome is total opioid consumption during the first 14 postoperative days; secondary outcomes include additional pain-related metrics and safety.
Why it matters
Potential benefit: If successful, suzetrigine could reduce the need for opioids after surgery for high-risk patients.
How similar studies have gone: Previous non-opioid analgesics with nat‑lass comparisons have shown pain relief and opioid-sparing effects in surgical patients; this study uses a novel AI risk-stratification approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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University of California, San Diego
La Jolla, California, United States Recruiting
Study contacts
- Principal investigator: Rodney A Gabriel, MD, MAS — University of California, San Diego
- Study coordinator: Rodney A Gabriel
- Email: ragabriel@health.ucsd.edu
- Phone: 858-663-7747
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.