E. L. McDonald, J. N. Daniel, R. G. Rogero, R. J. Shakked, K. Nicholson, D. I. Pedowitz, S. M. Raikin, B. S. Winters, Rothman Orthopaedic Institute, Philadelphia, PA, USA.
E. L. McDonald, R. G. Rogero, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Clin Orthop Relat Res. 2020 Jan;478(1):144-151. doi: 10.1097/CORR.0000000000000978.
The investigation of nonnarcotic drug regimens for postoperative pain management is important in addressing the opioid epidemic. NSAIDs can be a powerful adjunct in managing postoperative pain, but the possibility of delayed bone healing is a major concern for orthopaedic surgeons. Our recent retrospective study on ketorolac administration demonstrated that the NSAID is not associated with an increased risk of delayed union or nonunion after ankle fracture surgery.
QUESTIONS/PURPOSES: To determine whether postoperative ketorolac (1) reduces opioid consumption, (2) improves VAS pain control, and (3) affects fracture healing after open reduction and internal fixation of ankle fractures.
Between August 2016 and December 2017, 128 patients undergoing open reduction and internal fixation of an acute ankle fracture were randomized before surgery via simple randomization to treatment with or without ketorolac. No patients changed treatment regimen groups or opted out of randomization. All other aspects of perioperative care were treated identically. A once-daily survey was distributed via email on postoperative Days 1 to 7. Unblinded participants were asked to report their daily opioid consumption, pain level, and sleep interference using the VAS, and pain frequency using a five-point Likert scale, and side effects with the VAS. For VAS pain, > 20 mm/100 mm on the VAS scale was required to be considered "improved." In all, 83% (106 of 128) patients completed all seven postoperative surveys with 14 in the control group and eight in the ketorolac group lost to follow-up. Fifty-six patients were administered ketorolac with opioid medication (treatment group) and 50 were administered opioids alone (control group). Participants were comprised of 42% men (44), and 58% women (62); mean age was 48 years. The treating surgeon assessed clinical healing based on the patient's ability to ambulate comfortably at 12 weeks postoperatively. Radiographic healing was assessed by two fellowship-trained orthopaedic foot and ankle surgeons blinded to the patient's name and time since surgery. The surgeons evaluated randomized standard ankle series (anteroposterior, mortise, and lateral) radiographs for resolution of each fracture line to determine fracture union, with delayed union being defined as fracture lines present on radiographs taken at 12-week postoperative visits. Intention-to-treat analysis was performed.
Patients in the treatment group consumed a mean of 14 opioid pills, which was less than the mean of 19.3 opioids pills consumed by patients in the control group (p = 0.037). Patients with ketorolac had lower median VAS scores for pain (p < 0.035) postoperatively on postoperative Days 1 and 2 than did control patients. By contrast, patient-reported pain scores and scores for sleep did not convincingly show a benefit to the use of ketorolac. For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961).
In this randomized study, adding ketorolac to the postoperative drug regimen decreased the use of opioid medication after open reduction and internal fixation of ankle fractures in the early postoperative period, and there were mixed, small effects on pain reduction. This NSAID is a valuable tool in helping patients manage postoperative pain with less use of narcotic analgesia. However, our study was underpowered to determine the true safety of this drug in terms of fracture healing and side effects and these questions warrant higher-powered randomized study investigation.
Level I, therapeutic study.
在解决阿片类药物流行问题时，研究非麻醉性药物方案用于术后疼痛管理非常重要。非甾体抗炎药（NSAIDs）在管理术后疼痛方面可以发挥重要作用，但骨科医生主要关注的是延迟骨愈合的可能性。我们最近的一项关于酮咯酸给药的回顾性研究表明，该 NSAID 与踝关节骨折手术后的愈合延迟或不愈合无关。
问题/目的：确定术后酮咯酸是否 (1) 减少阿片类药物的消耗，(2) 改善 VAS 疼痛控制，以及 (3) 影响踝关节骨折切开复位内固定后的骨折愈合。
在 2016 年 8 月至 2017 年 12 月期间，128 例接受急性踝关节骨折切开复位内固定的患者在手术前通过简单随机化分组，分别接受或不接受酮咯酸治疗。没有患者改变治疗方案组或退出随机分组。所有其他围手术期护理方面均采用相同的方法。术后第 1 至 7 天通过电子邮件每天分发一次问卷调查。未设盲的参与者被要求使用视觉模拟量表（VAS）报告他们的每日阿片类药物消耗量、疼痛水平和睡眠干扰情况，使用五点 Likert 量表报告疼痛频率，并使用 VAS 报告副作用。VAS 疼痛方面，VAS 量表上 > 20 mm/100 mm 被认为是“改善”。总共 83%（128 例中的 106 例）患者完成了所有 7 次术后调查，其中对照组中有 14 例和治疗组中有 8 例失访。56 例患者接受了酮咯酸联合阿片类药物治疗（治疗组），50 例患者单独使用阿片类药物治疗（对照组）。参与者中 42%为男性（44 例），58%为女性（62 例）；平均年龄为 48 岁。治疗医生根据患者术后 12 周时舒适行走的能力评估临床愈合情况。放射学愈合由两名接受过足部和踝关节矫形外科专业培训的骨科医生评估，他们对患者的姓名和手术时间均设盲。医生评估随机标准踝关节系列（前后位、关节面和侧位）X 光片以确定每个骨折线的愈合情况，以确定骨折愈合，骨折愈合延迟定义为在 12 周术后就诊时 X 光片上仍存在骨折线。采用意向治疗分析。
治疗组患者平均服用 14 片阿片类药物，少于对照组患者平均服用的 19.3 片阿片类药物（p = 0.037）。与对照组患者相比，服用酮咯酸的患者术后第 1 天和第 2 天的 VAS 疼痛评分中位数较低（p < 0.035）。相比之下，患者报告的疼痛评分和睡眠评分并没有明显显示使用酮咯酸的益处。对于在 12 周时踝关节骨折愈合的患者，两组在临床愈合（p = 0.575）和放射学愈合（p = 0.961）方面没有差异。
在这项随机研究中，在踝关节骨折切开复位内固定术后的早期阶段，将酮咯酸加入术后药物治疗方案中可减少阿片类药物的使用，并且在减轻疼痛方面有较小的混合效果。这种 NSAID 是帮助患者管理术后疼痛的有价值的工具，减少了对阿片类镇痛药物的使用。然而，我们的研究在确定这种药物在骨折愈合和副作用方面的真正安全性方面力量不足，这些问题需要更高功率的随机研究调查。
一级，治疗性研究。
