Transition From Acute to Chronic Opioid Use and Chronic Pain
WithdrawnEarly phase 1NCT07211399
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- The Role of Intraoperative Opioids in the Transition From Acute to Chronic Opioid Use and Chronic Pain
- Conditions
- Interventions
- Drug: Opioid-free anesthesia
- Drug: Opioid-based anesthesia
- Sponsor
- Jacques E. Chelly
- Organization
- University of Pittsburgh
- Start date
- 2026-07-01
- Primary completion
- 2030-12-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07211399