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NCT07672015 · ClinicalTrials.gov registry record · Phase 4
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)
A Phase 4 study, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT07672015 is a Phase 4 study that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 100 participants.
The verdict
NCT07672015, a Phase 4 study, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study 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.
Interventions
- DRUG Suzetrigine
- DRUG Standard Care (in control arm)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-07-02 |
| Est. Completion | 2027-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07672015
The ClinicalTrials.gov registry entry for NCT07672015 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Suzetrigine is the first listed.
NCT07672015 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07672015 about?
NCT07672015 is a clinical study titled "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)". 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...
What is the current status of trial NCT07672015?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2026-07-02. Estimated completion is 2027-06.
What interventions are being tested in trial NCT07672015?
The interventions under investigation include: Suzetrigine (DRUG), Standard Care (in control arm) (DRUG).
Who is sponsoring clinical trial NCT07672015?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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