Opioid-Free Forefoot Surgery vs Traditional Perioperative Opiate Regimen: A Randomized Controlled Trial
Abstract
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]; p90% 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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 51 participants or records.
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