Steadman Philippon Research Institute, Vail, Colorado, U.S.A.
Henry Ford Hospital, Department of Orthopaedic Surgery, Detroit, Michigan, U.S.A.
Arthroscopy. 2022 Apr;38(4):1077-1085. doi: 10.1016/j.arthro.2021.11.028. Epub 2021 Nov 25.
To evaluate the efficacy of a multimodal nonopioid analgesic protocol in controlling postoperative pain compared to opioids following a primary arthroscopic rotator cuff repair.
Seventy consecutive patients undergoing a primary rotator cuff repair were assessed for eligibility. An observer-blinded prospective randomized controlled trial was designed in accordance with the Consolidated Standards of Reporting Trials 2010 (CONSORT) statement. The two arms of the study included a multimodal nonopioid pain regimen for the experimental group, and a standard of care narcotics for the control group. The primary outcome was visual analog scale (VAS) pain scores for the first 10 postoperative days. Secondary outcomes included PROMIS-PI (Patient-Reported Outcomes Measurement Information System-Pain Interference) scale, patient satisfaction, and adverse drug events.
Thirty patients declined to participate or were excluded, and 40 patients were included in the final analysis. A total of 23 patients were in the traditional group, and 17 patients were in the nonopioid group. Control patients on opioid pain management reported a significantly higher VAS pain score on postoperative day 1 (opioid: 5.7 ± 2, nonopioid: 3.7 ± 2.2; P = .011) and postoperative day 4 (opioid: 4.4 ± 2.7, nonopioid: 2.4 ± 2.2; P = .023). No significant difference was seen on any other postoperative day. When mixed measured models were used to control for confounding factors, the nonopioid group demonstrated significantly lower VAS and PROMIS-PI scores (P < .01) at every time point. Patients in the traditional analgesia group reported significantly more days with constipation (P = .003) and days with upset stomach (P = .020) than those in the nonopioid group.
The present study found that a multimodal nonopioid pain protocol provided equivalent or better pain control compared to traditional opioid analgesics in patients undergoing primary arthroscopic rotator cuff repair. Minimal side effects were noted with some improvement in the multimodal nonopioid pain cohort. All patients reported satisfaction with their pain management.
Level I, prospective randomized controlled trial.
评估与阿片类药物相比，多模式非阿片类镇痛方案在控制原发性关节镜肩袖修复术后疼痛方面的疗效。
对 70 例符合条件的连续行原发性肩袖修复术的患者进行评估。根据 CONSORT 2010 声明（CONSORT 声明）设计了一项观察者盲前瞻性随机对照试验。该研究的两个组包括实验组的多模式非阿片类镇痛方案和对照组的标准护理阿片类药物。主要结果是术后 10 天内的视觉模拟评分（VAS）疼痛评分。次要结果包括 PROMIS-PI（患者报告的结果测量信息系统-疼痛干扰）量表、患者满意度和不良药物事件。
30 例患者拒绝参与或被排除，最终有 40 例患者纳入最终分析。共有 23 例患者在传统组，17 例患者在非阿片类组。接受阿片类药物疼痛管理的对照组患者术后第 1 天（阿片类药物：5.7 ± 2，非阿片类药物：3.7 ± 2.2；P =.011）和术后第 4 天（阿片类药物：4.4 ± 2.7，非阿片类药物：2.4 ± 2.2；P =.023）的 VAS 疼痛评分显著更高。在其他任何术后日都没有明显差异。当使用混合测量模型控制混杂因素时，非阿片类组在每个时间点的 VAS 和 PROMIS-PI 评分均显著更低（P <.01）。传统镇痛组的患者报告有更多的便秘天数（P =.003）和胃部不适天数（P =.020），而非阿片类组的患者。
本研究发现，与传统阿片类药物相比，多模式非阿片类疼痛方案在接受原发性关节镜肩袖修复术的患者中提供了等效或更好的疼痛控制。多模式非阿片类疼痛组的副作用最小，且疼痛管理满意度有所提高。所有患者均报告对其疼痛管理满意。
1 级，前瞻性随机对照试验。
