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Opioid-Free pain control for teens after scoliosis surgery: a safer way?

NCT ID NCT06935331

Symptom relief Sponsor: OrthoCarolina Research Institute, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new opioid-free pain management plan to the usual opioid-based approach for teenagers (ages 10-20) having spinal fusion surgery for scoliosis. The opioid-free plan uses a mix of numbing injections and non-opioid medications like gabapentin, ibuprofen, and acetaminophen. Researchers will measure pain levels, opioid use, hospital stay length, and any side effects to see if avoiding opioids works just as well.

What this could mean

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

Active substance
multimodal opioid-free pain regimen (clonidine, epinephrine, ropivacaine, toradol, gabapentin, ibuprofen, acetaminophen, diazepam)
What this could lead to
If successful, this could offer a safer, opioid-free way to manage pain after scoliosis surgery in teens, reducing the risk of opioid dependence and side effects.
What could go wrong
This is a small, single-center Phase 4 trial with only 58 participants, so results may not apply broadly. The opioid-free regimen may not control pain as effectively as traditional opioids for some patients.

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 4

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

Participants

About 58 people

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

Started

Oct 2025

Expected to finish

Dec 2027

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

10 to 20 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: * Pediatric patients (10-20 years of age at the time of surgery) * Diagnosis of idiopathic scoliosis * Undergoing primary instrumented PSF Exclusion Criteria: * Age \<10 years or \>20 years at time of surgery * Patients with non-idiopathic scoliosis etiology, ie neuromuscular or syndromic scoliosis * Patients undergoing non-fusion spinal surgeries, ie growing rods or tethering

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis

As listed by the trial registrant

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

Adolescent idiopathic scoliosis (AIS)

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

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

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