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前交叉韧带重建后能否消除阿片类药物?一项前瞻性、随机对照试验。

Can We Eliminate Opioids After Anterior Cruciate Ligament Reconstruction? A Prospective, Randomized Controlled Trial.

机构信息

Henry Ford Health System, Detroit, Michigan, USA.

Mayo Clinic Orthopedics and Sports Medicine, Rochester, Minneapolis, USA.

出版信息

Am J Sports Med. 2021 Dec;49(14):3794-3801. doi: 10.1177/03635465211045394. Epub 2021 Oct 20.

DOI:10.1177/03635465211045394
PMID:34668795
Abstract

BACKGROUND

Multimodal pain protocols have been effective for postsurgical pain control; however, no published protocol has been effective in eliminating opioid consumption.

PURPOSE

To compare a multimodal nonopioid pain protocol versus traditional opioid medication for postoperative pain control in patients undergoing anterior cruciate ligament reconstruction (ACLR).

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

A total of 90 patients undergoing primary ACLR were assessed for participation. We performed a prospective, randomized controlled trial in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement. The study arms were a multimodal nonopioid analgesic protocol (acetaminophen, ketorolac, diazepam, gabapentin, and meloxicam) and a standard opioid regimen (hydrocodone-acetaminophen), and the primary outcome was postoperative visual analog scale (VAS) pain scores for 10 days. Secondary outcomes included patient-reported outcomes, complications, and satisfaction. The observers were blinded, and the patients were not blinded to the intervention.

RESULTS

A total of 9 patients did not meet inclusion criteria, and 19 patients declined participation. Thus, 62 patients were analyzed, with 28 patients randomized to the opioid group and 34 to the multimodal nonopioid group. Patients receiving the multimodal nonopioid pain regimen demonstrated significantly lower VAS scores compared with patients who received opioid pain medication ( < .05). Patients were administered the Patient-Reported Outcomes Measurement and Information System Pain Interference Short Form, and no significant difference was found in patients' preoperative scores (opioid group, 58.6 ± 7.9; multimodal nonopioid group, 57.5 ± 7.4; = .385) and 1-week postoperative scores (opioid group, 66.3 ± 8.2; multimodal nonopioid group, 61.4 ± 8.8; = .147). When we adjusted for possible confounders (age, sex, body mass index, graft type), no significant differences in pain control were found between the 2 groups. The most common adverse effects for both groups were drowsiness and constipation, with no difference between the groups. All patients in the multimodal nonopioid group reported satisfactory pain management.

CONCLUSIONS

A multimodal nonopioid pain protocol provided at least equivalent pain control compared with traditional opioid analgesics in patients undergoing ACLR. Minimal side effects, which did not differ between groups, were noted, and all patients reported satisfaction with their pain management.

摘要

背景

多模式疼痛方案已被证明可有效控制术后疼痛;然而,目前尚无方案能有效消除阿片类药物的使用。

目的

比较多模式非阿片类药物方案与传统阿片类药物在接受前交叉韧带重建 (ACLR) 患者中的术后疼痛控制效果。

研究设计

随机对照试验;证据水平,1 级。

方法

共纳入 90 例接受初次 ACLR 的患者参与研究。我们按照 CONSORT(临床试验报告统一标准)2010 声明进行了前瞻性随机对照试验。研究组为多模式非阿片类镇痛方案(对乙酰氨基酚、酮咯酸、地西泮、加巴喷丁和甲氨蝶呤)和标准阿片类药物方案(氢可酮-对乙酰氨基酚),主要结局为术后 10 天的视觉模拟评分(VAS)疼痛评分。次要结局包括患者报告的结局、并发症和满意度。观察者设盲,患者不设盲。

结果

共有 9 例患者不符合纳入标准,19 例患者拒绝参与。因此,共分析了 62 例患者,其中 28 例患者被随机分配至阿片类药物组,34 例患者被随机分配至多模式非阿片类药物组。接受多模式非阿片类疼痛方案的患者 VAS 评分明显低于接受阿片类药物疼痛治疗的患者(<0.05)。患者接受了患者报告的结局测量和信息系统疼痛干扰简短量表(Patient-Reported Outcomes Measurement and Information System Pain Interference Short Form)评估,术前评分无显著差异(阿片类药物组为 58.6±7.9,多模式非阿片类药物组为 57.5±7.4;=0.385),术后 1 周评分也无显著差异(阿片类药物组为 66.3±8.2,多模式非阿片类药物组为 61.4±8.8;=0.147)。当我们调整可能的混杂因素(年龄、性别、体重指数、移植物类型)后,两组间的疼痛控制无显著差异。两组最常见的不良反应均为嗜睡和便秘,但组间无差异。多模式非阿片类药物组的所有患者均报告疼痛管理满意。

结论

多模式非阿片类疼痛方案在接受 ACLR 的患者中提供的疼痛控制与传统阿片类药物至少相当。两组的副作用均较少,且无差异,所有患者均报告对其疼痛管理满意。

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