An Opioid-Free Perioperative Pain Protocol Is Noninferior to Opioid-Containing Management: A Randomized Controlled Trial.

Abstract

Background: In recent years, orthopaedic surgeons have attempted to decrease opioid consumption through multimodal pain management. However, a limited effort has been made to eliminate opioids entirely in the perioperative period. The purpose of this study was to compare the efficacy and safety of a novel opioid-free pain management pathway with that of an opioid-containing pathway across 5 common orthopaedic subspecialty surgical procedures.

Methods: In a 1:1, unblinded fashion, 315 patients were randomized to a perioperative pain management pathway that was either opioid-free (n = 157) or opioid-containing (n = 158). Pain was measured with a numeric rating scale (NRS) for pain of 0 to 10 at 6 hours, 12 hours, 24 hours (the primary outcome assessing noninferiority), 2 weeks, 6 weeks, and 1 year after the surgical procedure. Data on patient characteristics, deviations from the pain management pathway, morphine milligram equivalents (MME), readmissions, adverse events, and patient-reported outcomes were collected.

Results: There were 315 patients in the final group, with a mean age of 63.6 years. Of the patients in the study, 59.7% were female, 85.7% were White, 12.4% were Black/African-American, 1.0% were Hispanic/Latino, 0.6% were American Indian, and 0.3% were unknown. At 24 hours, the median NRS for pain in the opioid-free group (2 [interquartile range (IQR), 0 to 4]) was statistically noninferior (p < 0.0001) to the opioid-containing group (4 [IQR, 2 to 6]). Pain levels were significantly lower in the opioid-free group than in the opioid-containing group at 12 hours (p = 0.0173) and 2 weeks (p = 0.0003). Pain scores at 6 hours, 6 weeks, and 1 year were similar. Patients in the opioid-free group reported significantly greater comfort at 24 hours (p = 0.0392) and higher satisfaction with pain control (p = 0.0355) at 6 weeks. There were no reported adverse events or unplanned readmissions. Demographic characteristics were similar between the 2 groups.

Conclusions: Across 5 common orthopaedic subspecialty procedures, an opioid-free pain management pathway was safe and effective and provided noninferior pain control at 24 hours compared with the opioid-containing pathway.

Level of evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.