Abstract
Objectives:
The purpose of this study is to evaluate the potential analgesic effects of buccal-absorbed cannabidiol (CBD) in patients that have undergone arthroscopic rotator cuff repair (ARCR).
Methods:
This is an FDA sanctioned, multi-center, placebo-controlled, randomized, double-blinded trial conducted in patients undergoing ARCR. Patients from 18 to 75 years of age undergoing an ARCR were prospectively enrolled. Patients were equally randomized to the control and experimental groups. The experimental group post-operatively received 25mg of CBD (Oravexx, Orcosa Pharmaceuticals, USA) TID if < 80kg and 50mg of CBD TID if > 80kg for 14 days, with control groups receiving an identical placebo. Patients were followed-up on Day 1, 2, 7, and 14, and Visual Analog Scale (VAS) for pain, opioid consumption, and satisfaction with pain control were recorded. Additionally, liver function tests (LFT) were done on Days 7 and 14 to assess safety, and nausea was monitored. A priori power analysis was performed based on the VAS score as primary endpoint, which revealed that a minimum of 39 patients would be required in each group to detect a clinically important difference in the VAS score (1.4) with a power of 0.8. A value of p < 0.05 was considered to be statistically significant.
Results:
Overall, 80 patients were recruited. There were no significant differences in age, sex, or BMI between the two groups. On Day 1, VAS pain score was significantly lower in those receiving CBD (4.1 ± 3.0 vs 6.0 ± 3.1, p = 0.01), which also meets VAS MCID for shoulder arthroscopy (1.2-1.4). Patient satisfaction with pain control trended towards significance favoring the CBD group (72% vs 60%, p = 0.072). However, there were no statistically significant differences in opioid consumption (16.4mme ± 12.7 vs 20.6mme ± 14.4, p = 0.186), which was relatively small in both groups. Notably, patients receiving 50 mg of CBD reported lower VAS scores at day 1 (3.9 ± 3.3 vs 4.6 ±2.5 ± 6.0 ± 3.1, p = 0.0394) and higher satisfaction with pain control at day 1 and 2 (8.1 ± 2.3, 5.8 ± 3.3, 5.9 vs 3.6, p = 0.0175 | 7.8 ± 1.8 vs 6.3 ± 3.0 6.0 ± 3.2, p = 0.05) compared to those receiving 25 mg of CBD and control group respectively. On Day 7 and Day 14, there were no statistically significant differences in VAS score, opioid consumption, or patient satisfaction with pain control (p>0.05 for all). There were no significant differences in nausea or LFTs post-operatively (p > 0.05).
Conclusions:
CBD is safe and effective in reducing pain in the immediate peri-operative period following ARCR and should be considered in post-operative multimodal pain control.
Summary of Major Kinematic Effects for LMORT Lesions and Repairs
