Alaia Michael J, Hurley Eoghan T, Vasavada Kinjal, Markus Danielle H, Britton Briana, Gonzalez-Lomas Guillem, Rokito Andrew S, Jazrawi Laith M, Kaplan Kevin
NYU Langone Health, New York, New York, USA.
Jacksonville Orthopaedic Institute, Jacksonville, Florida, USA.
Am J Sports Med. 2022 Sep;50(11):3056-3063. doi: 10.1177/03635465221109573. Epub 2022 Jul 29.
Despite the widespread use and sales of cannabidiol (CBD) products in the United States, there is a paucity of literature to evaluate its effectiveness, safety, or ideal route of administration for postoperative pain.
To evaluate the potential analgesic effects of buccally absorbed CBD in patients who have undergone arthroscopic rotator cuff repair (ARCR).
Randomized controlled trial; Level of evidence, 1.
This was a US Food and Drug Administration-sanctioned, multicenter, placebo-controlled, randomized, double-blinded trial conducted in patients undergoing ARCR. Patients aged from 18 to 75 years undergoing ARCR were prospectively enrolled and randomized to the control and experimental groups. The experimental group received an oral, buccally absorbed tablet containing 25 mg of CBD 3 times a day if <80 kg, or 50 mg of CBD 3 times a day if >80 kg, for 14 days postoperatively, while the control group received an identical placebo. Patients were followed up on days 1, 2, 7, and 14, and visual analog scale (VAS) for pain scores, opioid consumption, and satisfaction with pain control were recorded. Additionally, liver function tests were conducted on days 7 and 14 to assess safety, and nausea was monitored. < .05 was considered to be statistically significant.
Overall, 100 patients were recruited, with 1 patient being excluded, for a total of 99 patients. There were no significant differences in patient demographics between the 2 groups. On day 1, the VAS pain score was significantly lower in the CBD group than in the control group (4.4 ± 3.1 vs 5.7 ± 3.2, respectively; = .04), although this difference was no longer present on day 2 (4.7 ± 2.8 vs 5.3 ± 2.6, respectively; = .32). On both days 1 and 2, patient satisfaction with pain control was significantly higher in the CBD group than in the control group (day 1: 7.0 ± 3.0 vs 5.6 ± 3.7, respectively [ = .04]; day 2: 7.3 ± 2.5 vs 6.0 ± 3.3, respectively [ = .03]). The quantity of opioids consumed was low in both groups, and there were no statistically significant differences in opioid consumption ( > .05). On days 7 and 14, there were no statistically significant differences in VAS scores, opioid consumption, or patient satisfaction with pain control between the CBD and control groups ( > .05 for all). There were no significant differences in liver function test results postoperatively ( > .05).
Buccally absorbed CBD demonstrated an acceptable safety profile and showed significant promise in the reduction of pain in the immediate perioperative period after ARCR compared with the control. Further studies are currently ongoing to confirm dosing and effectiveness in other orthopaedic conditions.
NCT04672252 (ClinicalTrials.gov identifier).
尽管大麻二酚（CBD）产品在美国广泛使用且销量可观，但用于评估其对术后疼痛的有效性、安全性或理想给药途径的文献却很匮乏。
评估经口腔吸收的CBD对接受关节镜下肩袖修补术（ARCR）患者的潜在镇痛效果。
随机对照试验；证据等级为1级。
这是一项经美国食品药品监督管理局批准的、多中心、安慰剂对照、随机、双盲试验，研究对象为接受ARCR的患者。年龄在18至75岁之间、接受ARCR的患者被前瞻性纳入并随机分为对照组和试验组。试验组术后14天内，若体重<80 kg，则每天口服3次含25 mg CBD的口腔吸收片；若体重>80 kg，则每天口服3次含50 mg CBD的口腔吸收片，而对照组服用相同的安慰剂。在第1、2、7和14天对患者进行随访，记录疼痛视觉模拟评分（VAS）、阿片类药物消耗量以及对疼痛控制的满意度。此外，在第7天和第14天进行肝功能检查以评估安全性，并监测恶心情况。P < 0.05被认为具有统计学意义。
总体而言，共招募了100例患者，排除1例，最终纳入99例患者。两组患者的人口统计学特征无显著差异。在第1天，CBD组的VAS疼痛评分显著低于对照组（分别为4.4±3.1和5.7±3.2；P = 0.04），尽管在第2天这种差异不再存在（分别为4.7±2.8和5.3±2.6；P = 0.32）。在第1天和第2天，CBD组患者对疼痛控制的满意度均显著高于对照组（第1天：分别为7.0±3.0和5.6±3.7[P = 0.04]；第2天：分别为7.3±2.5和6.0±3.3[P = 0.03]）。两组阿片类药物消耗量均较低，且阿片类药物消耗量无统计学显著差异（P>0.05）。在第7天和第14天，CBD组和对照组之间的VAS评分、阿片类药物消耗量或患者对疼痛控制的满意度均无统计学显著差异（所有P>0.05）。术后肝功能检查结果无显著差异（P>0.05）。
与对照组相比，经口腔吸收的CBD显示出可接受的安全性，并在ARCR术后即刻围手术期减轻疼痛方面显示出显著前景。目前正在进行进一步研究以确认其在其他骨科疾病中的给药剂量和有效性。
NCT04672252（ClinicalTrials.gov标识符）
