A Non-Opioid pain drug takes aim at Surgery's opioid problem

NCT ID NCT07829718

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers at Ohio State University are studying whether suzetrigine, a non-opioid pain drug, lowers the amount of opioid painkillers patients need after lumbar spine fusion surgery. About 110 adults scheduled for one- to three-level fusion will receive suzetrigine before and for 14 days after surgery as part of standard care. The team will compare their opioid use in the first 48 hours with that of matched past patients who received standard pain care, and will also track pain scores, side effects, hospital stay, and discharge opioid prescriptions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
suzetrigine, a non-opioid pain drug given by mouth before and after spine surgery
What this could lead to
If suzetrigine lowers opioid use after spine surgery, it could give surgeons a non-opioid option for managing severe postoperative pain and shape a larger randomized trial.
What could go wrong
This is a single-center study that compares participants with suzetrigine against past patients rather than randomly assigned ones, so differences in care or patient mix could skew the results. The findings may not hold in a broader surgical population.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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