Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Ann Surg. 2023 Sep 1;278(3):408-416. doi: 10.1097/SLA.0000000000005960. Epub 2023 Jun 15.
To conduct a prospective, randomized controlled trial (RCT) of an enhanced recovery after surgery (ERAS) protocol in an elective spine surgery population.
Surgical outcomes such as length of stay (LOS), discharge disposition, and opioid utilization greatly contribute to patient satisfaction and societal healthcare costs. ERAS protocols are multimodal, patient-centered care pathways shown to reduce postoperative opioid use, reduced LOS, and improved ambulation; however, prospective ERAS data are limited in spine surgery.
This single-center, institutional review board-approved, prospective RCT-enrolled adult patients undergoing elective spine surgery between March 2019 and October 2020. Primary outcomes were perioperative and 1-month postoperative opioid use. Patients were randomized to ERAS (n=142) or standard-of-care (SOC; n=142) based on power analyses to detect a difference in postoperative opioid use.
Opioid use during hospitalization and the first postoperative month was not significantly different between groups (ERAS 112.2 vs SOC 117.6 morphine milligram equivalent, P =0.76; ERAS 38.7% vs SOC 39.4%, P =1.00, respectively). However, patients randomized to ERAS were less likely to use opioids at 6 months postoperatively (ERAS 11.4% vs SOC 20.6%, P =0.046) and more likely to be discharged to home after surgery (ERAS 91.5% vs SOC 81.0%, P =0.015).
Here, we present a novel ERAS prospective RCT in the elective spine surgery population. Although we do not detect a difference in the primary outcome of short-term opioid use, we observe significantly reduced opioid use at 6-month follow-up as well as an increased likelihood of home disposition after surgery in the ERAS group.
在择期脊柱手术患者中进行一项强化术后康复(ERAS)方案的前瞻性随机对照试验(RCT)。
住院时间(LOS)、出院去向和阿片类药物使用等手术结果极大地影响了患者满意度和社会医疗保健成本。ERAS 方案是一种多模式、以患者为中心的护理途径,已被证明可减少术后阿片类药物使用、缩短 LOS 和改善活动能力;然而,在脊柱手术中,前瞻性 ERAS 数据有限。
这是一项单中心、机构审查委员会批准的前瞻性 RCT,纳入 2019 年 3 月至 2020 年 10 月间接受择期脊柱手术的成年患者。主要结局是围手术期和术后 1 个月的阿片类药物使用。根据检测术后阿片类药物使用差异的功效分析,患者被随机分配到 ERAS(n=142)或标准护理(SOC;n=142)组。
两组患者住院期间和术后第一个月的阿片类药物使用无显著差异(ERAS 组 112.2 与 SOC 组 117.6 吗啡毫克当量,P=0.76;ERAS 组 38.7%与 SOC 组 39.4%,P=1.00)。然而,随机分配到 ERAS 组的患者在术后 6 个月时使用阿片类药物的可能性较小(ERAS 组 11.4%与 SOC 组 20.6%,P=0.046),且更有可能在术后出院回家(ERAS 组 91.5%与 SOC 组 81.0%,P=0.015)。
在这里,我们在择期脊柱手术患者中进行了一项新型 ERAS 前瞻性 RCT。尽管我们没有发现短期阿片类药物使用这一主要结局存在差异,但我们观察到 ERAS 组在 6 个月随访时阿片类药物使用明显减少,以及术后出院回家的可能性增加。