Transition From Acute to Chronic Opioid Use and Chronic Pain

Conditions

• Opioid Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Opioid-free anesthesia — DRUG
  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).
• Opioid-based anesthesia — DRUG
  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.

Study Details

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).

Key Dates

Start date

Jul 1, 2026

Status verified

Apr 2026

Primary completion

Dec 1, 2030

Completion

Dec 1, 2030

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Opioid-free anesthesia (OFA) Group
  Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine prior to intubation.
• Active Comparator: Opioid-based anesthesia (OBA) Group
  Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, and fentanyl prior to intubation.

Primary Outcome Measure

PACU Opioid Medication Administered [ Time Frame: Postoperative Day 5 ]

Central Contacts

• Amy Monroe, MPH, MBA
  412-623-6283
  [email protected]
• Carly Riedmann, MPH
  412-623-4147
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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