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WithdrawnEarly Phase 1

Transition From Acute to Chronic Opioid Use and Chronic Pain

NCT07211399 · Jacques E. Chelly

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

In the current opioid crisis, the use of opioids as the main pain management method is recognized as a consistent risk factor for chronic opioid use and the development of Opioid Use Disorder (OUD), as well as related complications like overdose fatalities among surgical patients. The most recent data suggests that 3.1%-10.5% of surgical patients are at risk of developing OUD. On average, there are over 40 million major surgeries that require post-op pain management, taking place in the United States each year. This puts over 1 million American surgical patients at risk for opioid dependency and misuse. This is a prospective randomized controlled intervention study that will examine the physical and emotional outcomes of surgical patients who receive intraoperative Opioid-Free Anesthesia (OFA) supplemented with Non-Opioid Analgesia (NOAs), and how this relates to surgical patients who receive intraoperative Opioid-Based Anesthesia (OBA).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • PACU Opioid Medication Administered

    Measured over Postoperative Day 5

  • PACU Non-Opioid Medication Administered

    Measured over Postoperative Day 5

  • PACU NRS Pain Score at Rest

    Measured over Postoperative Day 5

  • PACU NRS Pain Score with Movement

    Measured over Postoperative Day 5

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
UPMC Shadyside HospitalPittsburghPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07211399 on ClinicalTrials.gov →

Last updated in the registry 2026-06-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in