Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, New York, NY, USA.
Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA.
Clin Orthop Relat Res. 2021 Aug 1;479(8):1740-1751. doi: 10.1097/CORR.0000000000001684.
Patients often have moderate to severe pain after rotator cuff surgery, despite receiving analgesics and nerve blocks. There are many suggested ways to improve pain after rotator cuff surgery, but the effects of adopting a pathway that includes formal patient education, a long-acting nerve block, and extensive multimodal analgesia are unclear.
QUESTIONS/PURPOSES: (1) Does adoption of a clinical pathway incorporating patient education, a long-acting nerve block, and preemptive multimodal analgesia reduce the worst pain during the first 48 hours after surgery compared with current standard institutional practices? (2) Does adoption of the pathway reduce opioid use? (3) Does adoption of the pathway reduce side effects and improve patient-oriented outcomes?
From September 2018 to January 2020, 281 patients scheduled for arthroscopic ambulatory rotator cuff surgery were identified for this paired sequential prospective cohort study. Among patients in the control group, 177 were identified, 33% (58) were not eligible, for 11% (20) staff was not available, 56% (99) were approached, 16% (29) declined, 40% (70) enrolled, and 40% (70) were analyzed (2% [4] lost to follow-up for secondary outcomes after postoperative day 2). For patients in the pathway cohort, 104 were identified, 17% (18) were not eligible, for 11% (11) staff was not available, 72% (75) were approached, 5% (5) declined, 67% (70) enrolled, and 67% (70) were analyzed (3% [3] lost to follow-up for secondary outcomes after postoperative day 2). No patients were lost to follow-up for primary outcome; for secondary outcomes, four were lost in the control group and three in the pathway group after postoperative day 2 (p = 0.70). The initial 70 patients enrolled received routine care (control group), and in a subsequent cohort, 70 patients received care guided by a pathway (pathway group). Of the 205 eligible patients, 68% (140) were included in the analysis. This was not a study comparing two tightly defined protocols but rather a study to determine whether adoption of a pathway would alter patient outcomes. For this reason, we used a pragmatic (real-world) study design that did not specify how control patients would be treated, and it did not require that all pathway patients receive all components of the pathway. We developed the pathway in coordination with a group of surgeons and anesthesiologists who agreed to apply the pathway as much as was viewed practical for each individual patient. Patients in both groups received a brachial plexus nerve block with sedation. Major differences between the pathway and control groups were: detailed patient education regarding reasonable pain expectations with a goal of reducing opioid use (no formal educational presentation was given to the control), a long-acting nerve block using bupivacaine with dexamethasone (control patients often received shorter-acting local anesthetic without perineural dexamethasone), and preemptive multimodal analgesia including intraoperative ketamine, postoperative acetaminophen, NSAIDs, and gabapentin at bedtime, with opioids as needed (control patients received postoperative opioids but most did not get postoperative NSAIDS and no controls received gabapentin or separate prescriptions for acetaminophen). The primary outcome was the numerical rating scale (NRS) worst pain with movement 0 to 48 hours after block placement. The NRS pain score ranges from 0 (no pain) to 10 (worst pain possible). The minimum clinically important difference (MCID) [12] for NRS that was used for calculation of the study sample size was 1.3 [18], although some authors suggest 1 [13] or 2 [5] are appropriate; if we had used an MCID of 2, the sample size would have been smaller. Secondary outcomes included NRS pain scores at rest, daily opioid use (postoperative day 1, 2, 7, 14), block duration, patient-oriented pain questions (postoperative day 1, 2, 7, 14), and patient and physician adherence to pathway.
On postoperative day 1, pathway patients had lower worst pain with movement (3.3 ± 3.1) compared with control patients (5.6 ± 3.0, mean difference -2.7 [95% CI -3.7 to -1.7]; p < 0.001); lower scores were also seen for pain at rest (1.9 ± 2.3 versus 4.0 ± 2.9, mean difference -2.0 [95% CI -2.8 to -1.3]; p < 0.001). Cumulative postoperative opioid use (0-48 hours) was reduced (pathway oral morphine equivalent use was 23 ± 28 mg versus 44 ± 35 mg, mean difference 21 [95% CI 10 to 32]; p < 0.01). The greatest difference in opioid use was in the first 24 hours after surgery (pathway 7 ± 12 mg versus control 21 ± 21 mg, mean difference -14 [95% CI -19 to -10]; p < 0.01). On postoperative day 1, pathway patients had less interference with staying asleep compared with control patients (0.5 ± 1.6 versus 2.6 ± 3.3, mean difference -2.2 [95% CI -3.3 to -1.1]; p < 0.001); lower scores were also seen for interference with activities (0.9 ± 2.3 versus 1.9 ± 2.9, mean difference -1.1 [95% CI -2 to -0.1]; p = 0.03). Satisfaction with pain treatment on postoperative day 1 was higher among pathway patients compared with control patients (9.2 ± 1.7 versus 8.2 ± 2.5, mean difference 1.0 [95% CI 0.3 to 1.8]; p < 0.001). On postoperative day 2, pathway patients had lower nausea scores compared with control patients (0.3 ± 1.1 versus 1 ± 2.1, mean difference -0.7 [95% CI -1.2 to -0.1]; p = 0.02); lower scores were also seen for drowsiness on postoperative day 1 (1.7 ± 2.7 versus 2.6 ± 2.6, mean difference -0.9 [95% CI - 1.7 to -0.1]; p = 0.03).
Adoption of the pathway was associated with improvement in the primary outcome (pain with movement) that exceeded the MCID. Patients in the pathway group had improved patient-oriented outcomes and fewer side effects. This pathway uses multiple analgesic drugs, which may pose risks to elderly patients, in particular. Therefore, in evaluating whether to use this pathway, clinicians should weigh the effect sizes against the potential risks that may emerge with large scale use, consider the difficulties involved in adapting a pathway to local practice so that pathway will persist, and recognize that this study only enrolled patients among surgeons and the anesthesiologists that advocated for the pathway; results may have been different with less enthusiastic clinicians. This pathway, based on a long-lasting nerve block, multimodal analgesia, and patient education can be considered for adoption.
Level II, therapeutic study.
尽管接受了镇痛剂和神经阻滞,肩部袖套手术后患者仍经常出现中度至重度疼痛。有许多方法可以改善肩部袖套手术后的疼痛,但采用包括正式的患者教育、长效神经阻滞和广泛的多模式镇痛在内的途径的效果尚不清楚。
问题/目的:(1)采用包括患者教育、长效神经阻滞和预先多模式镇痛的临床路径是否会降低术后前 48 小时内的最严重疼痛,与当前的标准机构实践相比?(2)采用该途径是否会减少阿片类药物的使用?(3)采用该途径是否会减少副作用并改善以患者为中心的结果?
从 2018 年 9 月到 2020 年 1 月,对 281 名计划接受关节镜日间肩部袖套手术的患者进行了这项配对序贯前瞻性队列研究。在对照组中,有 177 名患者符合条件,其中 33%(58 名)不符合条件,11%(20 名)工作人员不可用,56%(99 名)患者接受了治疗,16%(29 名)患者拒绝,40%(70 名)患者接受了治疗,40%(70 名)患者接受了治疗。进行了分析(2%[4]名患者在术后第 2 天以后的次要结果的随访中丢失)。对于路径组的患者,有 104 名患者符合条件,其中 17%(18 名)不符合条件,11%(11 名)工作人员不可用,72%(75 名)患者接受了治疗,5%(5 名)患者拒绝,67%(70 名)患者接受了治疗,67%(70 名)患者接受了治疗。(3%[3]名患者在术后第 2 天以后的次要结果的随访中丢失)。没有患者在主要结果的随访中丢失;对于次要结果,对照组有 4 名患者在术后第 2 天丢失,路径组有 3 名患者丢失(p=0.70)。最初纳入的 70 名患者接受了常规治疗(对照组),随后在后续队列中,70 名患者接受了基于路径的治疗(路径组)。在 205 名符合条件的患者中,有 68%(140 名)患者纳入了分析。这不是一项比较两种严格定义的方案的研究,而是一项确定采用方案是否会改变患者结果的研究。因此,我们使用了一种实用(真实世界)研究设计,该设计没有具体说明如何治疗对照组患者,也没有要求路径组的所有患者都接受该方案的所有组成部分。我们与一组外科医生和麻醉师共同制定了该方案,他们同意尽可能为每位患者实施该方案。两组患者均接受臂丛神经阻滞加镇静治疗。路径组和对照组之间的主要区别在于:详细的患者教育,包括合理的疼痛预期,以减少阿片类药物的使用(对照组没有进行正式的教育介绍)、使用布比卡因加地塞米松的长效神经阻滞(对照组患者经常接受无周围神经地塞米松的短效局麻药)和预先的多模式镇痛,包括术中氯胺酮、术后对乙酰氨基酚、非甾体抗炎药和睡前加巴喷丁,如果需要,则使用阿片类药物(对照组患者术后使用阿片类药物,但大多数患者未使用术后非甾体抗炎药,也没有对照组患者接受加巴喷丁或单独的对乙酰氨基酚处方)。主要结果是阻滞放置后 0 至 48 小时的数字评定量表(NRS)最严重疼痛。NRS 疼痛评分范围从 0(无痛)到 10(可能的最严重疼痛)。用于计算研究样本量的最小临床重要差异(MCID)[12]为 1.3[18],尽管一些作者建议使用 1[13]或 2[5],如果我们使用 MCID 为 2,样本量会更小。次要结果包括休息时的 NRS 疼痛评分、术后第 1、2、7、14 天的每日阿片类药物使用量、阻滞持续时间、以患者为中心的疼痛问题(术后第 1、2、7、14 天)以及患者和医生对途径的依从性。
术后第 1 天,路径组患者的最严重运动疼痛(3.3±3.1)低于对照组患者(5.6±3.0,平均差异-2.7[95%CI-3.7 至-1.7];p<0.001);休息时的疼痛评分也较低(1.9±2.3 与 4.0±2.9,平均差异-2.0[95%CI-2.8 至-1.3];p<0.001)。术后(0-48 小时)的阿片类药物总使用量(0-48 小时)减少(路径组口服吗啡等效物用量为 23±28mg 与 44±35mg,平均差异 21[95%CI 10 至 32];p<0.01)。术后第 1 天的阿片类药物使用量差异最大(路径组 7±12mg 与对照组 21±21mg,平均差异-14[95%CI-19 至-10];p<0.01)。术后第 1 天,路径组患者的睡眠干扰程度低于对照组患者(0.5±1.6 与 2.6±3.3,平均差异-2.2[95%CI-3.3 至-1.1];p<0.001);活动干扰程度也较低(0.9±2.3 与 1.9±2.9,平均差异-1.1[95%CI-2 至-0.1];p=0.03)。术后第 1 天,路径组患者对疼痛治疗的满意度高于对照组患者(9.2±1.7 与 8.2±2.5,平均差异 1.0[95%CI 0.3 至 1.8];p<0.001)。术后第 2 天,路径组患者的恶心评分低于对照组患者(0.3±1.1 与 1±2.1,平均差异-0.7[95%CI-1.2 至-0.1];p=0.02);术后第 1 天的困倦程度也较低(1.7±2.7 与 2.6±2.6,平均差异-0.9[95%CI-1.7 至-0.1];p=0.03)。
采用该途径与超过 MCID 的主要结果(运动时疼痛)改善相关。路径组患者的以患者为中心的结果和副作用较少。该途径使用多种镇痛药物,这可能对老年患者构成风险。因此,在评估是否使用该途径时,临床医生应权衡效应大小与可能出现的潜在风险,考虑该途径适应当地实践的难度,以便该途径能够持续,并且应该认识到,本研究仅纳入了倡导该途径的外科医生和麻醉师;结果可能与不太热情的临床医生不同。该途径基于长效神经阻滞、多模式镇痛和患者教育,可以考虑采用。
治疗学研究,二级。