Transition From Acute to Chronic Opioid Use and Chronic Pain

NCT ID: NCT07211399

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Opioid-free anesthesia (OFA) Group

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

Group Type: EXPERIMENTAL

Opioid-free anesthesia

Intervention Type: 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 (OBA) Group

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

Group Type: ACTIVE_COMPARATOR

Opioid-based anesthesia

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine & Ketamine Group; Fentanyl Group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacques E. Chelly

OTHER

Sponsor Role: lead

Responsible Party

Jacques E. Chelly

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jacques Chelly, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, UPMC

Locations

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Amy Monroe, MPH, MBA

Role: CONTACT

monroeal@upmc.edu

412-623-6283

Carly Riedmann, MPH

Role: CONTACT

riedmannca@upmc.edu

412-623-4147

Facility Contacts

Amy Monroe, MPH, MBA

Role: primary

monroeal@upmc.edu

412-623-6283

Carly Riedmann, MPH

Role: backup

riedmannca@upmc.edu

412-623-4147

Other Identifiers

STUDY25050099

Identifier Type: -

Identifier Source: org_study_id