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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
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).
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.
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
PACU Opioid Medication Administered
Medications will be extracted from the electronic medical records. Opioid-based medications will be reported as mean(SD).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Postoperative Day 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.