Opioid-Free Forefoot Surgery vs Traditional Perioperative Opiate Regimen: A Randomized Controlled Trial.

Background: In response to the opioid epidemic, the use of multimodal pain management in orthopaedic surgery is increasing. Efforts to decrease opioid prescribing and opioid consumption among foot and ankle surgical patients are needed. The purpose of this study was to compare the efficacy and adverse events between 2 multimodal pain management pathways for forefoot surgical patients: standard opioid-containing (OC) and opioid-free (OF).

Methods: This is a single-center noninferior randomized controlled trial of 51 patients undergoing forefoot surgery allocated to one of 2 perioperative pain management treatments: opioid-free, multimodal (OF, n=27 patients), or traditional opioid-containing (OC, n=24 patients). Patient characteristics, creatine markers, pain (numeric rating scale [NRS]), general health (Veterans Rand 12-Item Health Survey [VR-12]), and depression were measured preoperatively. Postoperatively, pain was measured at 24-hour, 2-week, and 6-week time points. Satisfaction with pain control, complications, and general health were measured at 2 and 6 weeks.

Results: The OF group is statistically noninferior to the OC group and reported lower median pain scores at 24 hours (2 [IQR 0, 3] vs 6 [IQR 3.5, 7]; p<.0001) and 2 weeks (2 [IQR 1, 4] vs 4 [IQR 0, 3]; p=.018]. By 6 weeks, pain levels were similar between groups. More than 85% of all patients reported satisfaction with pain level at 2 weeks, which increased to >90% at 6 weeks. The VR-12 scores were similar between groups across all time points. At 2 weeks, 8 patients in each group reported constipation. By 6 weeks, all but 2 OC patients reported resolution. No other adverse events of postoperative wound complications, readmissions, medication reactions, thrombosis, or persistent pain were documented.

Conclusion: In forefoot surgery, the opioid-free pain management protocol was statistically noninferior to the opioid-containing protocol in reducing postoperative pain.

Level Of Evidence: Level II, prospective cohort study.