Spine FusionPhase 4NCT07829718
Suzetrigine (Journavx) for Pain Management After Spine Surgery
A Phase 4 study testing Suzetrigine (Journavx) in people with Spine Fusion and Postoperative Pain, run by Ohio State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spine Fusion, Postoperative Pain
- What is being tested?
- Suzetrigine (Journavx)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2026to 30 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation of Suzetrigine (Journavx) in Spine Surgery: Signal Characterization and Trial-Design Optimization Using Historical Controls
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.
Read the 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.
- Conditions
- Spine Fusion, Postoperative Pain
- Being tested
- Suzetrigine (Journavx)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suzetrigine (Journavx)Drug
Also called Journavx, VX-548
Suzetrigine administered as a 100 mg oral loading dose preoperatively followed by 50 mg orally every 12 hours for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine Plus Standard Multimodal Analgesia | Experimental | Participants undergoing elective posterior lumbar fusion surgery will receive suzetrigine (Journavx) in addition to standard multimodal analgesia. Suzetrigine will be administered as a 100 mg oral loading dose within 2 hours prior to surgery, followed by 50 mg orally every 12 hours for 14 days. Participants will also receive standard perioperative pain management according to the institutional Enhanced Surgical Recovery (ESR) spine surgery pathway, including acetaminophen, muscle relaxants, and opioid analgesics as clinically indicated. Outcomes will be compared with matched historical controls receiving standard multimodal analgesia without suzetrigine. Receives: Drug: Suzetrigine (Journavx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours postoperatively
Secondary outcomes (7)
Daily Total Opioid Consumption
Daily opioid consumption, expressed as MME, during hospitalization.
Measured: Postoperative Days 1-7 (up to hospital discharge)
Daily Intravenous Opioid Consumption
Daily intravenous opioid use, expressed as MME, during hospitalization.
Measured: Postoperative Days 1-7 (up to hospital discharge)
Postoperative Pain Burden
Time-weighted area under the curve (AUC) of postoperative pain intensity based on routinely collected pain scores.
Measured: 24 and 48 hours postoperatively
Time to First Opioid Rescue Medication
Time from initial suzetrigine administration to first rescue opioid administration
Measured: Up to hospital discharge (average 3-7 days)
Incidence of Opioid-Related Adverse Events
Occurrence of opioid-related adverse events including nausea and vomiting, constipation, urinary retention, respiratory depression, sedation, delirium, and pruritus
Measured: Day 14 (±7 days) after surgery
Time to First Ambulation
Time from surgery to first ambulation of at least three steps with an assistive device.
Measured: At first ambulation, up to hospital discharge (average 3-7 days)
Discharge Opioid Utilization
Total opioid consumption and opioid prescribing during the 14-day postoperative treatment period.
Measured: Day 14 (±7 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start13 Sep 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryan Ladd, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829718
- Sponsor's protocol ID
- STUDY20261199
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Suzetrigine (Journavx) in Spine Surgery: Signal Characterization and Trial-Design Optimization Using Historical Controls
- ClinicalTrials.gov ID
- NCT07829718
- Acronym / sponsor ID
- STUDY20261199
- Conditions
- Spine Fusion, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 13 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine Plus Standard Multimodal Analgesia | Experimental | Drug: Suzetrigine (Journavx)Participants undergoing elective posterior lumbar fusion surgery will receive suzetrigine (Journavx) in addition to standard multimodal analgesia. Suzetrigine will be administered as a 100 mg oral loading dose within 2 hours prior to surgery, followed by 50 mg orally every 12 hours for 14 days. Participants will also receive standard perioperative pain management according to the institutional Enhanced Surgical Recovery (ESR) spine surgery pathway, including acetaminophen, muscle relaxants, and opioid analgesics as clinically indicated. Outcomes will be compared with matched historical controls receiving standard multimodal analgesia without suzetrigine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suzetrigine (Journavx)Also: Journavx, VX-548Suzetrigine administered as a 100 mg oral loading dose preoperatively followed by 50 mg orally every 12 hours for 14 days. | Drug | Suzetrigine Plus Standard Multimodal Analgesia |
Primary outcome
Total Opioid Consumption During the First 48 Hours After Surgery
Time frame: 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.
7 secondary outcomes
Daily Total Opioid Consumption
Time frame: Postoperative Days 1-7 (up to hospital discharge)
Daily Intravenous Opioid Consumption
Time frame: Postoperative Days 1-7 (up to hospital discharge)
Postoperative Pain Burden
Time frame: 24 and 48 hours postoperatively
Time to First Opioid Rescue Medication
Time frame: Up to hospital discharge (average 3-7 days)
Incidence of Opioid-Related Adverse Events
Time frame: Day 14 (±7 days) after surgery
Time to First Ambulation
Time frame: At first ambulation, up to hospital discharge (average 3-7 days)
Discharge Opioid Utilization
Time frame: Day 14 (±7 days) after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan Ladd, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suzetrigine (Journavx) in people with Spine Fusion and Postoperative Pain, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Ladd, MD (614-688-9440, Bryan.Ladd@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption During the First 48 Hours After Surgery (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.