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腰椎融合术后加速康复:一项评估患者康复质量的随机对照试验。

Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery.

机构信息

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.

出版信息

Anesthesiology. 2020 Aug;133(2):350-363. doi: 10.1097/ALN.0000000000003346.

DOI:10.1097/ALN.0000000000003346
PMID:32433277
Abstract

BACKGROUND

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.

METHODS

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).

RESULTS

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).

CONCLUSIONS

Statistically significant gains in early recovery were achieved by an enhanced recovery pathway. However, significant clinical impact was not demonstrated.

摘要

背景

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。

方法

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)。

结果

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。

结论

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。

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