Transition From Acute to Chronic Opioid Use and Chronic Pain

NCT07211399 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY25050099
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• PACU Opioid Medication Administered

  Medications will be extracted from the electronic medical records. Opioid-based medications will be reported as mean(SD).

  Postoperative Day 5

• PACU Non-Opioid Medication Administered

  Medications will be extracted from the electronic medical records.Non-opioid-based medications will be reported as mean(SD).

  Postoperative Day 5

• PACU NRS Pain Score at Rest

  Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores at rest will be averaged and reported as mean(SD).

  Postoperative Day 5

• PACU NRS Pain Score with Movement

  Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores with movement will be averaged and reported as mean(SD).

  Postoperative Day 5

Study Arms (2)

Opioid-free anesthesia (OFA) Group

EXPERIMENTAL

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

Drug: Opioid-free anesthesia

Opioid-based anesthesia (OBA) Group

ACTIVE COMPARATOR

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

Drug: Opioid-based anesthesia

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).

Also known as: Dexmedetomidine & Ketamine Group

Opioid-free anesthesia (OFA) Group

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.

Also known as: Fentanyl Group

Opioid-based anesthesia (OBA) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Jacques E. Chelly: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jacques Chelly, MD, PhD, MBA

  University of Pittsburgh, UPMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

412-623-6283; monroeal@upmc.edu

Carly Riedmann, MPH

CONTACT

412-623-4147; riedmannca@upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective RCT aiming to examine the effectiveness of OFA on the reduction of postoperative acute and chronic pain and opioid use among 700 adult TKA patients.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)