A Randomized, Multicenter, Semiblinded, Noninferiority, Controlled Trial
Authors: Eske Kvanner Aasvang, M.D., Ph.D. et al
Anesthesiology 6 2017, Vol.126, 1043-1052.
Post anesthesia care unit (PACU) discharge without observation of lower limb motor function after spinal anesthesia has been suggested to significantly reduce PACU stay and enhance resource optimization and early rehabilitation but without enough data to allow clinical recommendations.
Methods: A multicenter, semiblinded, noninferiority randomized controlled trial of discharge from the PACU with or without assessment of lower limb motor function after elective total hip or knee arthroplasty under spinal anesthesia was undertaken. The primary outcome was frequency of a successful fast-track course (length of stay 4 days or less and no 30-day readmission). Noninferiority would be declared if the odds ratio (OR) for a successful fast-track course was no worse for those patients receiving no motor function assessment versus those patients receiving motor function assessment by OR = 0.68.
Results: A total of 1,359 patients (98.8% follow-up) were available for analysis (93% American Society of Anesthesiologists class 1 to 2). The primary outcome occurred in 92.2% and 92.0%, corresponding to no motor function assessment being noninferior to motor function assessment with OR 0.97 (95% CI, 0.70 to 1.35). Adverse events in the ward during the first 24 h occurred in 5.8% versus 7.4% with or without motor function assessment, respectively (OR, 0.77; 95% CI, 0.5 to 1.19, P = 0.24).
Conclusions: PACU discharge without assessment of lower limb motor function after spinal anesthesia for total hip or knee arthroplasty was noninferior to motor function assessment in achieving length of stay 4 days or less or 30-day readmissions. Because a nonsignificant tendency toward increased adverse events during the first 24 h in the ward was discovered, further safety data are needed in patients without assessment of lower limb motor function before PACU discharge.