New work performed at the OrthoCarolina Research Institute in Charlotte, North Carolina, the nonprofit research partner of OrthoCarolina, highlights a truly novel, scalable, opioid-free recovery protocol known as the CORE (Carolinas Opioid Reduction Effort) program.
The study, “An Opioid-Free Perioperative Pain Protocol Is Noninferior to Opioid-Containing Management: A Randomized Controlled Trial,” appears in the April 2, 2025, edition of The Journal of Bone and Joint Surgery.
The OrthoCarolina research team collected data from 315 patients who had been treated with one of five common orthopedic subspecialty procedures. The patients were randomized to a perioperative pain management pathway that was either:
- opioid-free (n = 157) or
- opioid-containing (n = 158).
Pain was measured on a scale of 0 to 10 at:
- 6 hours,
- 12 hours,
- 24 hours,
- 2 weeks,
- 6 weeks, and
- 1 year after the surgical procedure.
At 24 hours, the median numeric rating scale for pain in the opioid-free group was statistically noninferior to the opioid-containing group.
At 12 hours and two weeks, pain levels were significantly lower in the opioid-free group than in the opioid-containing group.
At 6 hours, 6 weeks and 1 year pain scores were similar.
In terms of comfort at 24 hours the opiod-free group reported significantly greater comfort.
In terms of satisfaction with pain control, at six weeks, the opioid-free group reported higher satisfaction.
There were no reported adverse events or unplanned readmissions. Demographic characteristics were similar between the two groups.
The Carolinas Opioid Reduction Effort is an orthopedic-specific, clinically validated protocol that includes EMR integration through Epic, and has over $1 million in philanthropic funding from The Duke Endowment to scale the program statewide.
According to OrthoCarolina, this program also is different from other Enhanced Recovery After Surgery protocols in that it is opioid-free by default and represents a shift in prescribing culture.
OrthoCarolina indicates that if a patient is not a candidate for the opioid-free protocol, there are still opportunities to minimize the use of opioids. The EMR integration is fundamental to helping facilitate communication between patient and physician in reducing the use of opioids across the board. Because the protocol is embedded directly into Epic EMR, scalable provider decision support is possible, something that isn’t typically seen in most Enhanced Recovery After Surgery protocols.
Commenting to OTW was co-author Nady Hamid, M.D., an orthopedic shoulder and elbow surgeon at OrthoCarolina. He noted, “What makes CORE [Carolinas Opioid Reduction Effort] different is that it’s not just about reducing opioid use; the project was designed to eliminate it entirely for some patients. As orthopedic surgeons, we wanted to prove that an opioid-free recovery option is not only possible, but scalable. Our peer-reviewed study showed no increase in pain or complications, and the fact that patients are asking for this change tells us the culture is ready to shift. This new protocol is setting a new standard.”