BACKGROUND Appropriate analgesic protocols for patients following arthroscopic rotator cuff repair remain controversial. Although transdermal buprenorphine patches might potentially provide better pain control and fewer side effects, it is worth noting that there is limited evidence for this given a lack of direct comparisons with oral pain regimens. QUESTIONS/PURPOSES Among patients undergoing arthroscopic rotator cuff repair, and compared with an analgesic approach using oral tramadol plus celecoxib: (1) Does perioperative use of buprenorphine patches provide better pain relief by a clinically important margin? (2) Does perioperative use of buprenorphine patches improve shoulder joint function recovery? (3) Does perioperative use of buprenorphine patches have a lower frequency of adverse reactions? METHODS This was a prospective, single-center, randomized controlled trial. We included patients who underwent arthroscopic rotator cuff repair for partial- or full-thickness rotator cuff tears < 3 cm in size in the anterior to posterior direction as estimated by preoperative MRI and excluded those who had obesity, were pregnant, had opioid dependence, had history of cardiac bypass surgery or ipsilateral rotator cuff repair, had allergies to trial medications, were taking anticoagulants or antidepressants, were being treated with other postsurgical pain management methods, or had severe liver or kidney dysfunction. Based on these criteria, 64% (72 of 112) of patients were eligible. The patients were randomly assigned into either the control group (oral tramadol and celecoxib) or the experimental group (buprenorphine patches). The control group received 100 mg of tramadol and 200 mg of celecoxib every 12 hours for 2 weeks after surgery. The experimental group received buprenorphine patches about 48 hours before surgery without any oral medication. A medication journal was given to the patients to self-report their compliance in taking the drugs. The dosage regimen adhered strictly to protocol. After enrollment, 11% (4 of 36) of patients in the control group and 17% (6 of 36) of patients in the experimental group could not be fully analyzed because of loss to follow-up or missing data. The surveillance period was 3 months, and there was no crossover between groups. The groups did not differ at baseline in terms of demographic parameters and relevant clinical characteristics, including age, gender, BMI, American Society of Anesthesiologists classification, tear size, concomitant procedures, and number of anchors. The outcomes were (1) numeric rating scale (NRS) for pain score at rest or with movement, which ranges from 0 to 10, where 0 indicates no pain, and 10 indicates the worst pain; (2) the American Shoulder and Elbow Surgeons (ASES) score for joint function, which ranges from 0 to 100, with higher scores indicating better shoulder joint function; and (3) the incidence of postoperative adverse reactions. We defined the minimum clinically important difference on the NRS as 2 of 10 points and on the ASES score as 15 of 100 points, based on anchor-based approaches reported in other studies. RESULTS We found no clinically important between-group differences in NRS pain scores at any time point, either at rest or with movement. Likewise, we found no clinically important between-group differences in ASES scores at any time point. Postoperative dizziness or drowsiness (20% [6 of 30 patients] versus 44% [14 of 32 patients]; p = 0.04) and nausea (10% [3 of 30 patients] versus 34% [11 of 32 patients]; p = 0.02) during the hospital stay were slightly lower in the experimental group compared with the control group. CONCLUSION In this randomized trial, we found no clinically important advantages in pain or function to the use of buprenorphine patches after arthroscopic rotator cuff repair, and insufficient evidence exists to confirm whether the minor differences in transient side effects could justify the use of a new and largely untested analgesic approach in this context. That being so, we recommend against the routine use of buprenorphine patches for this indication. In general, we found that pain levels were low after the procedure in both groups. Future studies, therefore, should focus on the efficacy of buprenorphine patches for more invasive or more painful procedures. LEVEL OF EVIDENCE Level I, therapeutic study.

中文翻译：

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使用丁丙诺啡透皮贴剂治疗关节镜肩袖修复术后镇痛是否比口服药物更有效？一项随机临床试验。


背景 关节镜下肩袖修复术后患者的适当镇痛方案仍然存在争议。尽管透皮丁丙诺啡贴剂可能提供更好的疼痛控制和更少的副作用，但值得注意的是，鉴于缺乏与口服疼痛方案的直接比较，证据有限。问题/目的 在接受关节镜下肩袖修复术的患者中，与口服曲马多加塞来昔布的镇痛方法相比： （1） 围手术期使用丁丙诺啡贴剂是否能更好地缓解临床重要边缘的疼痛？（2） 围手术期使用丁丙诺啡贴剂是否能改善肩关节功能的恢复？（3） 围手术期使用丁丙诺啡贴剂的不良反应频率是否较低？方法 这是一项前瞻性、单中心、随机对照试验。我们纳入了因术前 MRI 估计的部分或全层肩袖撕裂 < 前后 3 cm 大小 < 而接受关节镜肩袖修复术的患者，并排除了肥胖、怀孕、有阿片类药物依赖、有心脏搭桥手术或同侧肩袖修复史、对试验药物过敏、 正在服用抗凝剂或抗抑郁药，正在接受其他术后疼痛管理方法治疗，或患有严重的肝或肾功能障碍。根据这些标准，64% （112 人中的 72 人） 符合条件。将患者随机分配到对照组 （口服曲马多和塞来昔布） 或实验组 （丁丙诺啡贴剂）。对照组术后每 12 小时接受 100 mg 曲马多和 200 mg 塞来昔布，持续 2 周。 实验组在手术前约 48 小时接受丁丙诺啡贴剂，未接受任何口服药物。向患者提供一份药物日志，以自我报告他们服药的依从性。剂量方案严格遵守方案。入组后，对照组 11% （36 名中的 4 名） 和实验组 17% （36 名） 患者由于失访或数据缺失而无法进行全面分析。监测期为 3 个月，组间无交叉。各组在人口统计学参数和相关临床特征方面没有差异，包括年龄、性别、BMI、美国麻醉医师协会分类、撕裂大小、伴随手术和锚定数量。结局是 （1） 静息或运动时疼痛评分的数字评定量表 （NRS），范围从 0 到 10，其中 0 表示没有疼痛，10 表示疼痛最严重;（2） 美国肩肘外科医生 （ASES） 关节功能评分，范围从 0 到 100，分数越高表示肩关节功能越好;（3） 术后不良反应的发生率。根据其他研究中报告的基于锚的方法，我们将 NRS 的最小临床重要差异定义为 10 分中的 2 分，ASES 评分定义为 100 分中的 15 分。结果 我们发现 NRS 疼痛评分在任何时间点都没有临床意义的组间差异，无论是在休息时还是在运动时。同样，我们在任何时间点发现 ASES 评分均无临床意义的组间差异。术后头晕或嗜睡 （20% [30 名患者中的 6 名] 对 44% [32 名患者中的 14 名];p = 0.04）和恶心 （10% [30 名患者中的 3 名] 对 34% [32 名患者中的 11 名] ;p = 0。02） 与对照组相比，实验组住院期间略低。结论 在这项随机试验中，我们发现关节镜肩袖修复术后使用丁丙诺啡贴剂在疼痛或功能方面没有临床重要优势，并且没有足够的证据证实短暂副作用的微小差异是否可以证明在这种情况下使用一种新的且基本上未经测试的镇痛方法是合理的。既然如此，我们建议不要针对此适应症常规使用丁丙诺啡贴剂。总的来说，我们发现两组手术后的疼痛程度都较低。因此，未来的研究应侧重于丁丙诺啡贴剂对更具侵入性或更痛苦的手术的疗效。证据级别 I 级，治疗研究。