Summary

The purpose of this study is to evaluate 1-year functional outcomes among patients who previously underwent arthroscopic rotator cuff repair (ARCR) and received buccally-absorbed cannabidiol for post-operative pain management. We hypothesize that there will be no clinical differences in pain or shoulder function at one year follow up comparing those who receive CBD versus a placebo.

Abstract

Purpose

Cannabidiol (CDB) has been recently shown to positively impact patient pain and satisfaction immediately after arthroscopic rotator cuff repair. However, it is unclear if addition of CBD to a post-operative regimen will cause any changes in clinical outcomes. The purpose of this study is to evaluate 1-year functional outcomes among patients who previously underwent arthroscopic rotator cuff repair (ARCR) and received buccally-absorbed cannabidiol for post-operative pain management. We hypothesize that there will be no clinical differences in pain or shoulder function at one year follow up comparing those who receive CBD versus a placebo.

Methods

Included patients had previously completed participation in a FDA-sanctioned, multi-center, placebo-controlled, randomized, double-blinded trial to evaluate the potential analgesic effects of CBD post-ARCR. The experimental group post-operatively received 25-mg of CBD (Oravexx, Orcosa Pharmaceuticals, USA) TID if < 80-kg and 50-mg of CBD TID if > 80-kg for 14 days, with control groups receiving an identical placebo. Patients were contacted one year following their date of surgery to obtain the following patient-reported outcome scores: the Visual Analogue Scale (VAS) for pain and satisfaction, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES), and the Single Assessment Numeric Evaluation (SANE) rating. These scores, as well as ASES sub-components, were compared between the CBD group and placebo group. Continuous variables were compared within groups with Wilcoxon signed rank test and between groups with Kruskal-Wallis test. Fisher’s exact test was used to compare categorical variables between groups. P-values < 0.05 were considered significant.

Results

Overall, 62 patients of the 72 patients currently eligible for 1-year follow-up were recruited, achieving a response rate of 86.1%. There were no significant differences in age, sex, or BMI between the two cohorts. There were no significant differences found between placebo and CBD cohorts in the overall ASES score (95.1% vs 91.2%, p = 0.288); furthermore, no differences (p > 0.05) were found in each component of the 10-question daily activities of living scale. There were no significant differences with respect to the amount of anti-inflammatory pain medication taken on an average day, as reported on the ASES between placebo and CBD cohorts (0.23 pills ± 0.82 vs 0.50 ± 1.39; p = 0.365). No patients (0%) reported using any stronger pain medications, including opioids. There were no significant differences found in VAS pain score (0.77 ± 1.25 vs 0.91 ± 1.75, p = 0.721), VAS satisfaction (97.1% vs 97.2%, p = 0.927), and SANE score (92.4 vs 87.0, p = 0.065). All patients (100%) stated that surgery had met their expectations.

Conclusion

Peri-operative use of CBD for pain control among patients undergoing ARCR does not result in any significant deficits in patient-reported pain, satisfaction, or functional outcomes at 1-year post-operatively compared to a placebo control. These findings suggest that CBD can be considered in a post-operative multimodal pain management regimen without long-term detrimental effects.