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A Prospective, Randomized Controlled Trial of Enhanced Recovery After Surgery Demonstrates Increased Postoperative Discharge to Home and Reduced Opioid Use at 6 Months
Zarina S. Ali1, Ahmed Albayar1, Jessica Ngyuyen1, Ryan S. Gallagher1, Austin Borja1, Michael J. Kallan3, Eileen Maloney1, Paul J. Marcotte1, Ronald P. DeMatteo2, Neil R. Malhotra*1
1Neurosurgery, University of Pennsylvania, Philadelphia, PA; 2Surgery, University of Pennsylvania, Philadelphia, PA; 3Biostatistics, University of Pennsylvania, Philadelphia, PA

Surgical outcomes such as length of stay (LOS), discharge disposition, and opioid utilization greatly contribute to patient satisfaction and societal healthcare costs. Enhanced Recovery After Surgery (ERAS) protocols are multimodal, patient-centered care pathways designed to optimize surgical outcomes. We have previously reported retrospective and case-control pilot data across elective spine surgery patients. Initial results demonstrated that ERAS protocols correlated with reduced postoperative opioid use, reduced LOS, and improved early and overall ambulation compared to historical controls. However, the impact of the ERAS protocol on spine surgery outcomes has not been assessed in a prospective, randomized fashion. We conducted a prospective, randomized controlled trial to study the potential impact of an ERAS protocol in spine surgery.

This single-center, IRB-approved, prospective, randomized controlled trial enrolled consecutive adult patients undergoing elective spine surgery between March 2019 and October 2020. Outcomes were peri-operative and 1-month postoperative opioid use (primary), and 6- month opioid use, mobilization/ambulation, urinary catheter utilization, resource utilization (such as discharge disposition and LOS), and validated patient-reported outcome surveys (secondary). Based on power analyses to detect a difference of 50 morphine milligram equivalents (MME) in postoperative opioid use, patients were randomized to one of the two groups: ERAS (n=142) or standard of care (SOC; n=142). The ERAS protocol included targeted education, standardized multimodal pain control limiting opioid use, mobilization ambulation goals, and patient-focused medical and lifestyle modification.

Patients randomized to the ERAS protocol were more likely to be discharged to home after surgery (ERAS 91.5% vs SOC 81.0%, p=0.012) and less likely to use opioids at 6 months postoperatively (ERAS 11.4% vs. SOC 20.6%, p=0.046). Opioid use during hospitalization and the first postoperative month was reduced but not significantly different (ERAS 112.2 vs. SOC 117.6 MME, p= 0.76; ERAS 38.7% vs. SOC 39.4%, p=1.00 respectively). ERAS patients required less urinary catheterization (p=0.012) and had lower mean postoperative disability by the Oswalt Disability Index (ERAS 40.0 vs. SOC 45.3, p=0.047). There was no observable difference in mobilization, ambulation, LOS, readmissions, or return to work.

Here, we present a first-of-its-kind ERAS prospective randomized controlled trial for spine surgery. This study did not demonstrate a difference in the primary outcome of short-term opioid use. However, the ERAS protocol was associated with an increased likelihood of home disposition after surgery, less urinary catheterization, lower perceived disability, and reduced opioid use at 6-month follow-up among ERAS patients, outcomes with great importance to patients and payers.

Graphical abstract demonstrating enrollment, interventions, and outcomes for a randomized controlled trial of ERAS in spine surgery.

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