Shing Elaine Z, Leas Daniel, Michalek Caleb, Wally Meghan K, Hamid Nady
Carolinas Medical Center, Atrium Health Musculoskeletal Institute, P.O. Box 32861, Charlotte, NC, 28232, USA.
Carolina Neurosurgery and Spine Associates, Charlotte, NC, USA.
BMC Musculoskelet Disord. 2021 Jan 23;22(1):104. doi: 10.1186/s12891-021-03972-9.
The medical community is beginning to recognize the contribution of prescription opioids in the growing national opioid crisis. Many studies have compared the safety and efficacy of alternative analgesics to opioids, but none utilizing a completely opioid-free perioperative protocol in orthopedics.
We developed and tested an opioid-free perioperative analgesic pathway (from preoperative to postoperative period) among patients undergoing common elective orthopedic procedures. Patients will be randomized to receive either traditional opioid-including or completely opioid-free perioperative medications. This study is being conducted across multiple orthopedic subspecialties in patients undergoing the following common elective orthopedic procedures: single-level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty (THA), and total shoulder arthroplasty/reverse total shoulder arthroplasty (TSA/RTSA). The primary outcome measure is pain score at 24 h postoperatively. Secondary outcome measures include pain scores at additional time points, medication side effects, and several patient-reported variables such as patient satisfaction, quality of life, and functional status.
We describe the methods for a feasibility randomized controlled trial comparing opioid-free perioperative analgesics to traditional opioid-including protocols. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as disseminated to additional orthopedic and/or non-orthopedic surgical procedures. The ultimate goal of presenting this protocol is to aid recent efforts in reducing the impact of prescription opioids on the national opioid crisis.
The protocol was approved by the local institutional review board and registered with clinicaltrials.gov (Identifier: NCT04176783 ) on November 25, 2019, retrospectively registered.
医学界开始认识到处方阿片类药物在日益严重的全国性阿片类药物危机中所起的作用。许多研究比较了替代镇痛药与阿片类药物的安全性和有效性，但在骨科领域，尚无研究采用完全无阿片类药物的围手术期方案。
我们为接受常见择期骨科手术的患者制定并测试了一种无阿片类药物的围手术期镇痛途径（从术前到术后）。患者将被随机分组，接受包含传统阿片类药物或完全无阿片类药物的围手术期药物治疗。本研究在多个骨科亚专业中进行，涉及接受以下常见择期骨科手术的患者：单节段或双节段颈椎前路椎间盘切除融合术/颈椎前路椎间盘切除伴椎体间植骨融合术、第一掌腕关节置换术、拇外翻/僵硬拇趾矫正术、诊断性膝关节镜检查、全髋关节置换术（THA）以及全肩关节置换术/反式全肩关节置换术（TSA/RTSA）。主要结局指标是术后24小时的疼痛评分。次要结局指标包括其他时间点的疼痛评分、药物副作用以及一些患者报告的变量，如患者满意度、生活质量和功能状态。
我们描述了一项可行性随机对照试验的方法，该试验比较了无阿片类药物的围手术期镇痛药与包含传统阿片类药物的方案。我们展示这项研究，以便它能够在其他机构被复制并纳入未来的研究，同时推广到其他骨科和/或非骨科手术中。展示该方案的最终目标是协助近期减少处方阿片类药物对全国阿片类药物危机影响的努力。
该方案已获当地机构审查委员会批准，并于2019年11月25日在clinicaltrials.gov上注册（标识符：NCT04176783），为回顾性注册。
