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New combo therapy aims to cut opioid use in trauma patients

NCT ID NCT04705480

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving nerve pain medications pregabalin or gabapentin alongside standard opioids could lower the amount of opioids needed by adults hospitalized with orthopedic injuries. 109 participants were randomly assigned to receive one of the two add-on drugs. The goal was to see if this approach reduces opioid use while still controlling pain effectively.

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

109 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2024

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

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: 1. Nurse Practitioner service admissions 2. 18 years of age or older 3. Patients enrolled within 36 hours of admission 4. Anticipated duration of hospitalization \> 24 hours from time of consent 5. Active order(s) for opioids in place at the time of enrollment Exclusion Criteria: 1. Clinician discretion based on patient care management 2. Intubated patients 3. Patients with epidural 4. Patients with pregabalin/gabapentin as home medications 5. Patients receiving pregabalin/gabapentin upon admission 6. Traumatic brain injury patients 7. CrCl\<30ml/min or on HD 8. Unable to take enteral medications 9. On Patient Controlled Analgesia (PCA) 10. Patients with complicated wound closure 11. History of epilepsy 12. Documented history of substance use disorder

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Charleston Area Medical Center"s Level 1 Trauma Center

    Charleston, West Virginia, 25301, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.