NCT07211399

Transition From Acute to Chronic Opioid Use and Chronic Pain

The Role of Intraoperative Opioids in the Transition From Acute to Chronic Opioid Use and Chronic Pain

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Jacques E. Chelly · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Opioid-free anesthesia	Each patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and dexmedetomidine (12-20 mcg IV) and ketamine (25-50 mcg) prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, dexmedetomidine and ketamine will be administered as needed. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC).
DRUG	Opioid-based anesthesia	Each patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and fentanyl 50-100 mcg IV prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, each patient in the opioid group will receive IV-fentanyl (50 - 100 mcg) as needed.

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-10-08
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study