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NOT YET RECRUITING
NCT07829718
PHASE4

Suzetrigine (Journavx) for Pain Management After Spine Surgery

Sponsor: Ohio State University

View on ClinicalTrials.gov

Summary

This prospective, single-center interventional study will evaluate the effect of suzetrigine (Journavx), a selective NaV1.8 inhibitor, on postoperative opioid requirements in patients undergoing spine surgery. Participants receiving suzetrigine as part of standard perioperative care will be compared with matched historical controls treated with standard multimodal analgesia. The study aims to characterize the magnitude and variability of opioid-sparing effects during the immediate postoperative period, with primary assessment focused on inpatient opioid consumption during the first 48 hours after surgery. Secondary objectives include evaluation of postoperative pain scores, opioid-related adverse events, hospital length of stay, discharge disposition, post-discharge opioid prescribing patterns, and healthcare utilization. Findings from this study will provide real-world evidence regarding the potential role of suzetrigine in spine surgery and will inform the design and endpoint selection of a future multicenter randomized clinical trial.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-09-13

Completion Date

2030-12-30

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Suzetrigine (Journavx)

Suzetrigine administered as a 100 mg oral loading dose preoperatively followed by 50 mg orally every 12 hours for 14 days.