Spine Fusion, Postoperative Pain
Conditions
Brief 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.
Detailed description
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.
Interventions
Suzetrigine administered as a 100 mg oral loading dose preoperatively followed by 50 mg orally every 12 hours for 14 days.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. All prospective participants receive suzetrigine in addition to standard multimodal analgesia. Participants, care providers, investigators, and outcome assessors are aware of treatment assignment. Study outcomes are compared with matched historical controls.
Intervention model description
Single-arm prospective interventional study in which all enrolled participants receive suzetrigine in addition to standard multimodal analgesia. Outcomes will be compared with a matched historical control cohort derived from institutional data.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 80 years. Scheduled to undergo elective posterior-only lumbar fusion involving 1 to 3 spinal levels. Anticipated postoperative inpatient admission. Eligible for the institutional Enhanced Surgical Recovery (ESR) spine surgery pathway. Able and willing to provide informed consent.
Exclusion criteria
* 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. Prisoner at the time of surgery or hospitalization. Known pregnancy at the time of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption During the First 48 Hours After Surgery | 48 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Total Opioid Consumption | Postoperative Days 1-7 (up to hospital discharge) | Daily opioid consumption, expressed as MME, during hospitalization. |
| Daily Intravenous Opioid Consumption | Postoperative Days 1-7 (up to hospital discharge) | Daily intravenous opioid use, expressed as MME, during hospitalization. |
| Postoperative Pain Burden | 24 and 48 hours postoperatively | Time-weighted area under the curve (AUC) of postoperative pain intensity based on routinely collected pain scores. |
| Time to First Opioid Rescue Medication | Up to hospital discharge (average 3-7 days) | Time from initial suzetrigine administration to first rescue opioid administration |
| Incidence of Opioid-Related Adverse Events | Day 14 (±7 days) after surgery | Occurrence of opioid-related adverse events including nausea and vomiting, constipation, urinary retention, respiratory depression, sedation, delirium, and pruritus |
| Time to First Ambulation | At first ambulation, up to hospital discharge (average 3-7 days) | Time from surgery to first ambulation of at least three steps with an assistive device. |
| Discharge Opioid Utilization | Day 14 (±7 days) after surgery | Total opioid consumption and opioid prescribing during the 14-day postoperative treatment period. |
Contacts
CONTACTBryan Ladd, MD
PRINCIPAL_INVESTIGATORBryan Ladd, MD
Ohio State University
Outcome results
None listed