Prospective Evaluation of Suzetrigine (Journavx) in Spine Surgery: Signal Characterization and Trial-Design Optimization Using Historical Controls

Postoperative pain management following spine surgery remains a significant clinical challenge. Patients undergoing lumbar decompression, fusion, and other major spine procedures frequently experience substantial postoperative pain, require high doses of opioid analgesics, and are at increased risk for opioid-related adverse events, including postoperative nausea and vomiting, ileus, urinary retention, oversedation, respiratory depression, delirium, and delayed mobilization. Although multimodal analgesia strategies are widely implemented, the use of nonsteroidal anti-inflammatory drugs may be limited in fusion procedures because of concerns regarding bone healing, and regional anesthesia techniques are not universally applicable. Consequently, opioids remain a primary component of perioperative pain management in many spine surgery patients.

Suzetrigine (Journavx) is a first-in-class, selective NaV1.8 inhibitor that provides analgesia through peripheral inhibition of pain signaling without the central nervous system effects associated with opioids. Clinical studies in acute postoperative pain have demonstrated effective analgesia, reduced reliance on rescue medication, and a favorable safety profile. Given the high opioid requirements and substantial burden of opioid-related complications in spine surgery, this population represents an important setting in which to evaluate the potential opioid-sparing effects of suzetrigine.

This prospective, single-center study will evaluate postoperative outcomes among patients undergoing spine surgery who receive suzetrigine as part of perioperative pain management. Outcomes will be compared with matched historical controls treated with standard multimodal analgesia. The primary objective is to estimate the magnitude of opioid reduction during the first 48 hours after surgery. Secondary objectives include evaluation of inpatient and post-discharge opioid utilization, postoperative pain scores, opioid-related adverse events, hospital length of stay, discharge disposition, readmissions, and healthcare resource utilization.

In addition to assessing clinical outcomes, the study is intended to characterize variability in treatment response across patient and procedural subgroups and to identify the most informative efficacy, safety, clinical, and economic endpoints for future investigation. Findings from this study will generate real-world evidence regarding the use of suzetrigine in spine surgery and will inform the design, endpoint selection, and sample size considerations for a future multicenter randomized clinical trial.