Transition From Acute to Chronic Opioid Use and Chronic Pain

Jacques E. Chelly

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Opioid Use Disorder

Treatments: Drug: Opioid-based anesthesia; Drug: Opioid-free anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07211399

STUDY25050099

Details and patient eligibility

About

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).

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Opioid-free anesthesia (OFA) Group

Experimental group

Description:

Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine prior to intubation.

Treatment:

Drug: Opioid-free anesthesia

Opioid-based anesthesia (OBA) Group

Active Comparator group

Description:

Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, and fentanyl prior to intubation.

Treatment:

Drug: Opioid-based anesthesia