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关节镜下肩袖修复术后使用大麻二酚控制疼痛:与安慰剂相比,患者报告结局无差异的1年随机对照试验随访

Cannabidiol for Postoperative Pain Control After Arthroscopic Rotator Cuff Repair Demonstrates No Deficits in Patient-Reported Outcomes Versus Placebo: 1-Year Follow-up of a Randomized Controlled Trial.

作者信息

Alaia Michael J, Li Zachary I, Chalem Isabel, Hurley Eoghan T, Vasavada Kinjal, Gonzalez-Lomas Guillem, Rokito Andrew S, Jazrawi Laith M, Kaplan Kevin

机构信息

Department of Orthopedic Surgery, New York University Langone Health, New York, New York, USA.

Department of Orthopedic Surgery, Jacksonville Orthopaedic Institute, Jacksonville, Florida, USA.

出版信息

Orthop J Sports Med. 2024 Feb 5;12(2):23259671231222265. doi: 10.1177/23259671231222265. eCollection 2024 Feb.

Abstract

BACKGROUND

Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR). However, it is unclear whether the addition of CBD to a perioperative regimen could affect postoperative outcomes.

PURPOSE

To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 2.

METHODS

Eligible patients had previously participated in a multicenter, placebo-controlled, randomized, double-blinded trial that evaluated the analgesic effects of CBD in the immediate postoperative period after ARCR. The experimental group received 25 mg of CBD 3 times/day if <80 kg and 50 mg of CBD 3 times/day if >80 kg for 14 days, with the control group receiving an identical placebo. The following outcomes were assessed at minimum 1-year follow-up: visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and patient satisfaction. The rates of achievement of the Patient Acceptable Symptom State (PASS) were compared based on ASES at latest follow-up. Continuous and categorical variables were compared with the Mann-Whitney test and Fisher exact test, respectively.

RESULTS

Follow-up was obtained from 83 of 99 patients (83.8%) who completed the original trial. There were no significant differences between the CBD and control groups with respect to age, sex, body mass index, rate of concomitant procedures, or number of anchors used intraoperatively. At 1-year follow-up, there were no significant differences between the CBD and control groups in VAS pain (0.8 vs 1.2,  = .38), ASES (93.0 vs 91.1,  = .71), SANE (87.6 vs 90.1,  = .24), or satisfaction (97.4 vs 95.4,  = .41). A majority of patients achieved the PASS (81.0% [CBD] vs 77.5% [control];  = .79).

CONCLUSION

Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome.

REGISTRATION

NCT04672252 (ClinicalTrials.gov identifier).

摘要

背景

最近的研究表明,大麻二酚(CBD)对关节镜下肩袖修复术(ARCR)后的患者疼痛和满意度有积极影响。然而,围手术期方案中添加CBD是否会影响术后结果尚不清楚。

目的

评估接受ARCR并在术后1年随访时经口腔吸收CBD或相同安慰剂进行早期疼痛管理的患者报告的结果。

研究设计

随机对照试验;证据级别,2级。

方法

符合条件的患者之前参加了一项多中心、安慰剂对照、随机、双盲试验,该试验评估了ARCR术后即刻CBD的镇痛效果。实验组体重<80 kg者每天3次,每次服用25 mg CBD;体重>80 kg者每天3次,每次服用50 mg CBD,持续14天,对照组服用相同的安慰剂。在至少1年的随访中评估以下结果:疼痛视觉模拟量表(VAS)、美国肩肘外科医师协会(ASES)评分、单项评估数值评定法(SANE)和患者满意度。根据最新随访时的ASES比较患者可接受症状状态(PASS)的达成率。连续变量和分类变量分别采用Mann-Whitney检验和Fisher精确检验进行比较。

结果

99名完成原始试验的患者中有83名(83.8%)获得了随访。CBD组和对照组在年龄、性别、体重指数、同期手术率或术中使用的锚钉数量方面无显著差异。在1年随访时,CBD组和对照组在VAS疼痛评分(0.8对1.2,P = 0.38)、ASES评分(93.0对91.1,P = 0.71)、SANE评分(87.6对90.1,P = 0.24)或满意度(97.4对95.4,P = 0.41)方面无显著差异。大多数患者达到了PASS(CBD组为81.0%,对照组为77.5%;P = 0.79)。

结论

与安慰剂对照组相比,ARCR患者围手术期使用CBD进行疼痛控制在术后1年时在疼痛、满意度或患者报告的结果方面没有导致任何显著不足。这些发现表明,CBD可被纳入术后多模式疼痛管理方案,而不会对结果产生不利影响。

注册信息

NCT04672252(ClinicalTrials.gov标识符)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b557/10846110/ad2790a7c494/10.1177_23259671231222265-fig1.jpg

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