Background:

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.

Purpose:

To evaluate the potential analgesic effects of buccally absorbed CBD in patients who have undergone arthroscopic rotator cuff repair (ARCR).

Study Design:

Randomized controlled trial; Level of evidence, 1.

Methods:

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. P < .05 was considered to be statistically significant.

Results:

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; P = .04), although this difference was no longer present on day 2 (4.7 ± 2.8 vs 5.3 ± 2.6, respectively; P = .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 [P = .04]; day 2: 7.3 ± 2.5 vs 6.0 ± 3.3, respectively [P = .03]). The quantity of opioids consumed was low in both groups, and there were no statistically significant differences in opioid consumption (P > .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 (P > .05 for all). There were no significant differences in liver function test results postoperatively (P > .05).

Conclusion:

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.

Registration:

NCT04672252 (ClinicalTrials.gov identifier).

中文翻译：

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经颊吸收的大麻二酚在关节镜下肩袖修复后立即显示出显着优越的疼痛控制和改善的满意度：安慰剂对照、双盲、随机试验

背景：

尽管在美国广泛使用和销售大麻二酚 (CBD) 产品，但缺乏文献来评估其有效性、安全性或术后疼痛的理想给药途径。

目的：

评估口腔吸收 CBD 在接受关节镜下肩袖修复 (ARCR) 的患者中的潜在镇痛作用。

学习规划：

随机对照试验; 证据水平，1。

方法：

这是一项美国食品和药物管理局批准的、多中心、安慰剂对照、随机、双盲试验，在接受 ARCR 的患者中进行。接受 ARCR 的 18 至 75 岁的患者被前瞻性纳入并随机分配到对照组和实验组。实验组术后 14 天服用含 25 mg CBD 的口服含 CBD 片剂，每日 3 次（如果 <80 kg）或 50 mg CBD 每日 3 次（如果 >80 kg），持续 14 天。安慰剂。在第 1、2、7 和 14 天对患者进行随访，并记录疼痛评分、阿片类药物消耗和对疼痛控制的满意度的视觉模拟量表 (VAS)。此外，在第 7 天和第 14 天进行肝功能测试以评估安全性，并监测恶心。磷< .05 被认为具有统计学意义。

结果：

总体而言，招募了 100 名患者，其中 1 名患者被排除在外，总共 99 名患者。两组之间的患者人口统计学没有显着差异。第 1 天，CBD 组的 VAS 疼痛评分显着低于对照组（分别为 4.4 ± 3.1 vs 5.7 ± 3.2；P = .04），尽管这种差异在第 2 天不再存在（4.7 ±分别为 2.8 和 5.3 ± 2.6；P = .32）。在第 1 天和第 2 天，CBD 组的患者对疼痛控制的满意度显着高于对照组（第 1 天：7.0 ± 3.0 vs 5.6 ± 3.7 [ P = .04]；第 2 天：7.3 ± 2.5分别与 6.0 ± 3.3 [ P= .03]）。两组的阿片类药物消耗量均较低，阿片类药物消耗量差异无统计学意义（P > .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差异（均P > .05）。术后肝功能检查结果差异无统计学意义（P > .05）。

结论：

与对照组相比，经颊吸收的 CBD 表现出可接受的安全性，并显示出在 ARCR 后即刻围手术期减轻疼痛的显着前景。目前正在进行进一步的研究，以确认在其他骨科疾病中的剂量和有效性。

登记：

NCT04672252（ClinicalTrials.gov 标识符）。