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Can Anti-Inflammatories after spine surgery reduce opioid use without harming healing?

NCT ID NCT07743606

Disease control Sponsor: Rothman Institute Orthopaedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial compares two pain management approaches after lumbar spine fusion surgery: standard pain medication alone versus standard care plus a short course of NSAIDs (ketorolac in the hospital and naproxen for a week after discharge). The main question is whether adding NSAIDs affects bone healing, specifically the risk of needing another surgery due to failed fusion. The study also tracks pain medication use, recovery, complications, and patient-reported outcomes to see if NSAIDs can safely reduce opioid reliance.

What this could mean

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

Active substance
ketorolac and naproxen (NSAIDs)
What this could lead to
If NSAIDs prove safe, they could become a standard part of pain management after spine fusion, potentially reducing opioid use.
What could go wrong
The trial is still in progress, and results may show that NSAIDs increase the risk of failed bone healing, leading to more surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 428 people

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

Started

Jul 2024

Expected to finish

Dec 2028

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * ≥18 years of age, ≥1-level planned lumbar spinal fusion * Capacity to enroll * English speaking Exclusion Criteria: * Chronic kidney disease (preoperative creatinine ≥1.4) * History of gastrointestinal bleed or peptic ulcer disease * History of spinal fusion nonunion * Non-steroidal anti-inflammatory drug allergy * Previously diagnosed coagulopathy * Preoperative thrombocytopenia (platelets \<100,000) * Connective tissue disease * Operative indication due to infection, neoplasm, or trauma * Currently pregnant

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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.

Ketorolac Lumbar spine fusion Nsaid (non-steroidal anti-inflammatory drug) Postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania, 19107, United States

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