Transition From Acute to Chronic Opioid Use and Chronic Pain
Key facts
- Who runs it
- Jacques E. Chelly
- Where
- Pittsburgh, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Early phase 1
- Started
- 1 Jul 2026
- Expected to end
- 1 Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Opioid-free anesthesia
- Opioid-based anesthesia
- Record updated
- 30 June 2026
- Why it stopped
- Study did not receive funding.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- ≥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
Who cannot take part
- received intraoperative opioids other than fentanyl
- received patient-controlled analgesia in PACU
- <18 years of age
- sent to the ICU at any point during their hospital stay
- scheduled for a bilateral TKA
Where in United States
- UPMC-Shadyside HospitalPittsburgh, United States
About the trial
What the trial wants to find out
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.
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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).
The 2 groups in the trial
- Opioid-free anesthesia (OFA) GroupTreatment being tested
Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine prior to intubation.
Treatment: Opioid-free anesthesia
- Opioid-based anesthesia (OBA) GroupExisting treatment, for comparison
Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, and fentanyl prior to intubation.
Treatment: Opioid-based anesthesia
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Role of Intraoperative Opioids in the Transition From Acute to Chronic Opioid Use and Chronic Pain
- Record updated
- 30 June 2026