Suzetrigine (Journavx) for Pain Management After Spine Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 80 years. Scheduled to undergo elective posterior-only lumbar fusion involving 1 to 3 spinal levels.
Disqualifiers
Known contraindication or hypersensitivity to suzetrigine. Chronic or daily opioid use prior to surgery. Clinically significant hepatic or renal dysfunction. Inability or unwillingness to comply with study procedures or follow-up assessments.
Trial design
Design model
Single group
Treatments tested in this trial
Suzetrigine (Journavx)
DrugSuzetrigine administered as a 100 mg oral loading dose preoperatively followed by 50 mg orally every 12 hours for 14 days.
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Suzetrigine Plus Standard Multimodal AnalgesiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total Opioid Consumption During the First 48 Hours After Surgery
Total inpatient opioid consumption, expressed as morphine milligram equivalents (MME), during the first 48 hours following surgery. Opioid use among participants receiving suzetrigine will be compared with matched historical controls receiving standard multimodal analgesia.
Time frame
48 hours postoperativelySecondary outcomes
1
Daily Total Opioid Consumption
Daily opioid consumption, expressed as MME, during hospitalization.
Time frame
Postoperative Days 1-7 (up to hospital discharge)2
Daily Intravenous Opioid Consumption
Daily intravenous opioid use, expressed as MME, during hospitalization.
Time frame
Postoperative Days 1-7 (up to hospital discharge)3
Postoperative Pain Burden
Time-weighted area under the curve (AUC) of postoperative pain intensity based on routinely collected pain scores.
Time frame
24 and 48 hours postoperatively4
Time to First Opioid Rescue Medication
Time from initial suzetrigine administration to first rescue opioid administration
Time frame
Up to hospital discharge (average 3-7 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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