From the Departments of Anesthesiology, Critical Care and Pain Management, (E.M.S., J.D.B., A.T., M.U., C.R.G., J.A.N., I.F.A., S.G.M.) Orthopedic Surgery (R.C.H., H.-J.K., F.P.C., F.J.S.) the Biostatistics Core (H.Z.), Hospital for Special Surgery, New York, New York; and Weill Cornell Medical College, New York, New York.
Anesthesiology. 2020 Aug;133(2):350-363. doi: 10.1097/ALN.0000000000003346.
Prospective trials of enhanced recovery after spine surgery are lacking. We tested the hypothesis that an enhanced recovery pathway improves quality of recovery after one- to two-level lumbar fusion.
A patient- and assessor-blinded trial of 56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed. The primary outcome was Quality of Recovery-40 score (40 to 200 points) at postoperative day 3. Twelve points defined the clinically important difference. Secondary outcomes included Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein).
The analysis included 25 enhanced recovery patients and 26 usual care patients. Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference. There were no significant differences in recovery scores at days 0 (175 ± 16 vs. 162 ± 22; P = 0.059), 1 (174 ± 18 vs. 164 ± 15; P = 0.050), 2 (174 ± 18 vs. 167 ± 17; P = 0.289), 14 (184 ± 13 vs. 180 ± 12; P = 0.500), and 56 (187 ± 14 vs. 190 ± 8; P = 0.801). In the enhanced recovery group, subscores on the Quality of Recovery-40 comfort dimension were higher (longitudinal mean score difference, 4; 95% CI, 1, 7; P = 0.008); time to oral intake (-3 h; 95% CI, -6, -0.5; P = 0.010); and duration of intravenous patient-controlled analgesia (-11 h; 95% CI, -19, -6; P < 0.001) were shorter; opioid consumption was lower at day 1 (-57 mg; 95% CI, -130, -5; P = 0.030) without adversely affecting pain scores (-2; 95% CI, -3, 0; P = 0.005); and C-reactive protein was lower at day 3 (6.1; 95% CI, 3.8, 15.7 vs. 15.9; 95% CI, 6.6, 19.7; P = 0.037).
Statistically significant gains in early recovery were achieved by an enhanced recovery pathway. However, significant clinical impact was not demonstrated.
缺乏脊柱手术后加速康复的前瞻性试验。我们检验了一个假说,即增强康复路径可以改善一到两级腰椎融合术后的康复质量。
对 56 名患者进行了患者和评估者双盲的试验,这些患者随机分配到增强康复组(17 项基于证据的术前、术中和术后护理要素)或常规护理组。主要结局是术后第 3 天的恢复质量-40 评分(40 至 200 分)。12 分定义了具有临床意义的差异。次要结局包括术后第 0 至 2、14 和 56 天的恢复质量-40 评分;口服摄入时间和物理治疗出院时间;住院时间;数字疼痛评分(0 至 10);阿片类药物消耗量(吗啡当量);静脉自控镇痛使用时间;并发症;以及手术应激标志物(白细胞介素 6、皮质醇和 C 反应蛋白)。
分析包括 25 名增强康复组患者和 26 名常规护理组患者。增强康复组患者在术后第 3 天的恢复质量-40 评分显著更高(179±14 比 170±16;P=0.041),但未达到具有临床意义的差异。在术后第 0 天(175±16 比 162±22;P=0.059)、第 1 天(174±18 比 164±15;P=0.050)、第 2 天(174±18 比 167±17;P=0.289)、第 14 天(184±13 比 180±12;P=0.500)和第 56 天(187±14 比 190±8;P=0.801),两组患者的恢复评分均无显著差异。在增强康复组中,恢复质量-40 舒适度维度的亚评分更高(纵向平均评分差异,4;95%置信区间,1,7;P=0.008);口服摄入时间(提前 3 小时;95%置信区间,6,0.5;P=0.010)和静脉自控镇痛使用时间(提前 11 小时;95%置信区间,19,6;P<0.001)更短;阿片类药物消耗量在第 1 天(减少 57 毫克;95%置信区间,130,5;P=0.030)更少,而不会影响疼痛评分(减少 2 分;95%置信区间,3,0;P=0.005);第 3 天的 C 反应蛋白水平(6.1;95%置信区间,3.8,15.7 比 15.9;95%置信区间,6.6,19.7;P=0.037)更低。
通过增强康复途径,在早期康复方面取得了统计学上显著的收益。然而,并没有显示出显著的临床影响。