Opioid Use Disorder
Conditions
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).
Interventions
DRUGOpioid-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).
DRUGOpioid-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.
Sponsors
Jacques E. Chelly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PACU Opioid Medication Administered | Postoperative Day 5 | Medications will be extracted from the electronic medical records. Opioid-based medications will be reported as mean(SD). |
| PACU Non-Opioid Medication Administered | Postoperative Day 5 | Medications will be extracted from the electronic medical records.Non-opioid-based medications will be reported as mean(SD). |
| PACU NRS Pain Score at Rest | Postoperative Day 5 | 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). |
| PACU NRS Pain Score with Movement | Postoperative Day 5 | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacques Chelly, MD, PhD, MBA
University of Pittsburgh, UPMC
Outcome results
None listed