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Can skipping opioids during surgery curb addiction? new trial aims to find out

NCT ID NCT07211399

Disease control Sponsor: Jacques E. Chelly 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study will test whether using opioid-free anesthesia during knee replacement surgery can reduce the risk of long-term opioid use and chronic pain. About 700 adults scheduled for knee replacement will be randomly assigned to receive either standard opioid-based anesthesia or an opioid-free combination of other pain medicines. Researchers will track pain levels and opioid use after surgery to see if the opioid-free approach leads to better long-term outcomes.

What this could mean

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

Active substance
Opioid-free anesthesia (dexmedetomidine, ketamine, lidocaine, acetaminophen, propofol, sevoflurane)
What this could lead to
If it works, this could show that avoiding opioids during surgery lowers the risk of opioid addiction and chronic pain after knee replacement.
What could go wrong
This is a very early, small study (700 people) testing a new approach. It may not prove effective, and the opioid-free method might not control pain as well as standard care.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Expected to start

Jul 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 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: * ≥18 years old * scheduled for an elective, unilateral Total Knee Arthroplasty (TKA) * anticipated to stay in PACU after surgery * receiving general anesthesia (i.e. fentanyl, etc.) * receiving spinal regional anesthesia Exclusion Criteria: * \<18 years of age * sent to the ICU at any point during their hospital stay * scheduled for a bilateral TKA * received intraoperative opioids other than fentanyl * received patient-controlled analgesia in PACU

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

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

Opioid use disorder

Contacts and locations

Locations

  • UPMC Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232, United States

More trials for these conditions

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