Importance In arthroscopic knee and shoulder surgery, there is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients' pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. Objective To evaluate the effect of a multimodal, opioid-sparing approach to postoperative pain management compared with the current standard of care in patients undergoing arthroscopic shoulder or knee surgery. Design, Setting, and Participants This randomized clinical trial was performed at 3 clinical sites in Ontario, Canada, and enrolled 200 patients from March 2021 to March 2022 with final follow-up completed in April 2022. Adult patients undergoing outpatient arthroscopic shoulder or knee surgery were followed up for 6 weeks postoperatively. Interventions The opioid-sparing group (100 participants randomized) received a prescription of naproxen, acetaminophen (paracetamol), and pantoprazole; a limited rescue prescription of hydromorphone; and a patient educational infographic. The control group (100 participants randomized) received the current standard of care determined by the treating surgeon, which consisted of an opioid analgesic. Main Outcomes and Measures The primary outcome was postoperative oral morphine equivalent (OME) consumption at 6 weeks after surgery. There were 5 secondary outcomes, including pain, patient satisfaction, opioid refills, quantity of OMEs prescribed at the time of hospital discharge, and adverse events at 6 weeks all reported at 6 weeks after surgery. Results Among the 200 patients who were randomized (mean age, 43 years; 73 women [38%]), 193 patients (97%) completed the trial; 98 of whom were randomized to receive standard care and 95 the opioid-sparing protocol. Patients in the opioid-sparing protocol consumed significantly fewer opioids (median, 0 mg; IQR, 0-8.0 mg) than patients in the control group (median, 40.0 mg; IQR, 7.5-105.0; z = -6.55; P < .001). Of the 5 prespecified secondary end points, 4 showed no significant difference. The mean amount of OMEs prescribed was 341.2 mg (95% CI, 310.2-372.2) in the standard care group and 40.4 mg (95% CI, 39.6-41.2) in the opioid-sparing group (mean difference, 300.8 mg; 95% CI, 269.4-332.3; P < .001). There was no significant difference in adverse events at 6 weeks (2 events [2.1%] in the standard care group vs 3 events [3.2%] in the opioid-sparing group), but more patients reported medication-related adverse effects in the standard care group (32% vs 19%, P = .048). Conclusions and Relevance Among patients who underwent arthroscopic knee or shoulder surgery, a multimodal opioid-sparing postoperative pain management protocol, compared with standard opioid prescribing, significantly reduced postoperative opioid consumption over 6 weeks. Trial Registration ClinicalTrials.gov Identifier: NCT04566250.

中文翻译：

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术后多模式阿片类药物节约方案与标准阿片类药物处方对膝关节或肩关节镜术后阿片类药物消耗的影响：一项随机临床试验。

重要性 在膝关节和肩关节镜手术中，越来越多的证据表明，阿片类药物节约方案可以减少术后阿片类药物的消耗，同时充分解决患者的疼痛问题。然而，缺乏评估其有效性的前瞻性比较试验。目的 评估多模式、阿片类药物保留方法与现行护理标准相比对接受关节镜肩或膝手术患者的术后疼痛管理的影响。设计、设置和参与者 这项随机临床试验在加拿大安大略省的 3 个临床试验点进行，从 2021 年 3 月至 2022 年 3 月招募了 200 名患者，最终随访于 2022 年 4 月完成。接受门诊关节镜肩关节或膝关节手术的成年患者术后随访 6 周。干预 阿片类药物保留组（100 名随机参与者）接受萘普生、对乙酰氨基酚（扑热息痛）和泮托拉唑的处方；氢吗啡酮的有限救助处方；和耐心的教育信息图。对照组（随机分配 100 名参与者）接受由主治外科医生确定的现行护理标准，其中包括阿片类镇痛剂。主要结果和测量 主要结果是术后 6 周的术后口服吗啡当量 (OME) 消耗量。有 5 个次要结果，包括疼痛、患者满意度、阿片类药物补充、出院时处方的 OME 数量以及 6 周时的不良事件，所有这些均在术后 6 周报告。结果 在随机分组的 200 名患者中（平均年龄 43 岁；73 名女性 [38%]），193 名患者 (97%) 完成了试验；其中 98 人被随机分配接受标准护理，95 人接受阿片类药物保留方案。与对照组患者（中位数，40.0 毫克；IQR，7.5-105.0；z = -6.55；P < . 001). 在 5 个预先指定的次要终点中，有 4 个没有显着差异。标准治疗组 OME 的平均处方量为 341.2 mg（95% CI，310.2-372.2），阿片类药物保留组为 40.4 mg（95% CI，39.6-41.2）（平均差，300.8 mg；95%置信区间，269.4-332.3；P < .001）。6 周时的不良事件无显着差异（标准治疗组 2 起事件 [2.1%] 对比阿片类药物保留组 3 起事件 [3.2%]），但更多患者报告了标准治疗组的药物相关不良反应（32% 对 19%，P = .048）。结论和相关性 在接受关节镜膝关节或肩关节手术的患者中，与标准阿片类药物处方相比，多模式阿片类药物保留术后疼痛管理方案可显着减少术后 6 周内阿片类药物的消耗量。试验注册 ClinicalTrials.gov 标识符：NCT04566250。