Cannabidiol is effective in improving immediate post-operative pain and patient satisfaction following arthroscopic rotator cuff repair, a placebo-controlled randomized double-blind study. My name is Mike Alea from NYU. Thanks to the AOSSM for having us present this data. Disclosures can be found on the Academy website. So as everybody here knows, arthroscopic rotator cuff repair is extremely common and it's quite painful. So instead of begging the question, how can we really maximize pain management after these surgeries? Which brings me to the concept of neuromodulation, specifically through the endocannabinoid system, which helps regulate inflammatory response to injury as well as modulate pain. The molecule in question here is cannabidiol or CBD. This is a non-psychotropic molecule. It's well tolerated. There's a low risk of side effects and there's no interaction with opioids. However, everywhere you look on the street, everybody seems to be an expert in selling CBD, whether it's in your coffee, whether it's in your massage oil, et cetera. You can pretty much get it anywhere. The problem is there's no data, there's no studies, there's no regulation, and theoretically there's no backbone behind any of this. So the purpose of our study was a double-blinded, multi-center randomized controlled trial to evaluate the use of buccal-absorbed cannabidiol in patients undergoing primary arthroscopic rotator cuff repair. We looked at post-operative pain, patient satisfaction, opioid use, and complications. We hypothesized that patients getting CBD would have decreased post-operative pain, improved patient satisfaction, as well as decreased opiate use. Going into the methods, this is a prospective, randomized, double-blinded, placebo-controlled phase 1-2 trial, which is IRB approved, and the FDA granted us an IND to perform this research. The intervention was a buccal-absorbed cannabidiol taken three times a day. The recruitment criteria you can see here, I won't delve into it, but the intervention consisted of an experimental and a control group. The experimental group received 25 milligrams or 50 milligrams of cannabidiol three times a day, as opposed to the control, which received an identical-looking, identical-tasting pill. All the patients received an intrascalene block, as well as Percocet post-operatively 5 over 325, and were instructed to stop taking this or wean down as soon as possible. Patients received a diary to ensure compliance with the protocol. The primary outcome was VAS pain score at multiple time points. Secondary outcomes included patient satisfaction, opiate use, nausea, as well as adverse effects. We conducted an a priori power analysis, which demonstrated that 94 patients would be required to detect a 1.4 point difference in the VAS at 90% power. Going into the results and the demographics, there was really no differences between the groups in terms of age, sex, BMI, concomitant, open biceps, tenodesis, et cetera. The size of the tears and numbers of the anchors used was also equivalent between the groups. Now getting into the meat of the data, this is VAS and satisfaction after the surgery and with the medication. You can see on post-operative day one, the VAS was significantly improved in patients undergoing the experimental group with CBD. That was statistically significant as it went down to day two, day four, excuse me, day seven, day 14. It lost statistical significance but did still demonstrate superiority. Looking at satisfaction on day one, two, seven, and 14, this achieved statistical significance in terms of CBD being favored and the results can be seen below. When we dose stratified this, and this is important, the patients that got 50 milligrams of CBD really did outperform the placebo. If you look at VAS on day one, there's almost a two-point difference in the VAS favoring the CBD 50 milligram group, and if you extrapolate that to the 25 milligram group, the results are less significant. We also see that this group, the 50 milligrams, did outperform at all the time points but did not achieve statistical significance at all of these time points. Delving further into patient satisfaction, you see on day one and day two, the CBD group really did outperform the placebo group at 50 milligrams, almost a two- or three-point difference in satisfaction out of 10 on day one and day two. Post-Hocktookie testing confirmed the stratification results that we found. When we looked at opioid consumption, unfortunately, there was really no statistically significant difference between the groups. We trended towards significance on day one, favoring the CBD group, but it did not reach significance. When we look at nausea and liver function tests, there was no difference in between the groups as well. In terms of suspected adverse events, two patients experienced a rash on day two, which resolved, and one patient experienced some increased nausea on post-operative day two. Neither one we could confidently attribute to the use of CBD. So the conclusions in our study, we found that buccal absorbed cannabidiol in patients undergoing primary arthroscopic cuff repair does show promise in improving immediate post-operative pain control and patient satisfaction while meeting safety standards. Additionally, no significant differences were seen in nausea or post-operative liver function. Further directions that our group that we're undertaking at NYU, we're looking at knee osteoarthritis, so chronic pain, we're looking at synovial biomarkers and whether CBD will change that in terms of osteoarthritis, dosing strategies, as well as now our one-year clinical outcomes of the patients that were in this study. So thank you very much for your time and attention.

double-blind

randomized controlled trial

buccal-absorbed cannabidiol

post-operative pain

patient satisfaction