Bill Klaproth (Host): This is an AAOMS On the Go Podcast. I'm Bill Klaproth. And with me is Dr. Elie Ferneini and Dr. Jeffrey James. They join us to discuss a study recently published in the Journal of Oral and Maxillofacial Surgery titled Pain Levels Did Not Differ Following Uncomplicated Third Molar Extractions Using Liposomal Bupivacaine Versus Standard Bupivacaine.

Dr. James and Dr. Ferneini, thank you so much and welcome. Dr. James, let's start with you. So, how did you and your team decide that this was worthy of research and what was the development process?

Dr. Jeffrey James: Sure. Despite it being published fairly recently, this idea was conceived quite a time before COVID even. And if you recall in those times, the hot topic of the country was the opioid epidemic. So, oral surgeons and the world of dentists obviously probably dish out more pain than the average dentist. And therefore, we certainly prescribed quite a bit of this.

And one of our obvious more common procedures, the wisdom teeth, seems to be a very good procedure to try some sort of novel approach to get around the prescription. So, that's sort of the thought process of it. And right around that time, Exparel or this liposomal bupivacaine sort of came around and was being used very readily in the bigger surgeries of like general surgery or orthopedic surgery, things like that. So, we were all, as a society, I think, just anecdotally very excited to see what this could do for us in our clinics. So, that's sort of where it all started, I'd say.

Host: Absolutely. Certainly worthy of research. So then, what was your development process? How did you go about this research?

Dr. Jeffrey James: For my end at that time, and really frankly still, I'm very much a novice in regards to research. You know, I was a new academician. And trying to get involved in figuring out how to do this was something I'll never forget. This study was the first prospective study that I've ever attempted. We were in a busy resident clinic. Academic center has all the things that academic centers have. And every oral surgeon out there will know what I mean when we talk about the resident clinics or whatnot. So, constructing this research, I certainly went to my mentors and got their advice on how to design it and whatnot, and then talk to statisticians to decide how many, people we needed to capture.

And then, the biggest thing in the world happened, right? COVID happened. So, this study was sort of right in the middle of that. And I have nightmares on this thing because we got audited by the IRB like every month through COVID on keeping our data proper and all that stuff. And this is all my first go at it. And so, it was a crazy time for all of us. And I was trying to get through this damn study and close the IRB as soon as possible, but it ended up stretching out three years.

Host: Wow. Yeah. So, did your study's conclusion then match your original hypothesis?

Dr. Jeffrey James: Yes and no. I think that we are all very hopeful that this was going to work, and we know it works from a physiological standpoint, you know, this liposomal bupivacaine. One of the things that's sort of a hard thing for us to use it for particularly wisdom teeth or particularly lower wisdom teeth, is we're not really using this medication as a peripheral nerve block. And as oral surgeons and the dentists, we really rely on that technique for anesthesia control or pain during procedures. And so when we take that away, then the usefulness of it was something to investigate. And that's kind of what we tried to look at and looked at some of the work that Liebeck did and try to recapitulate a little bit of that you know, adding our own errors into it and everything.

So, point is that in some manner, one could argue that this worked as we thought it would, and that is that we have less narcotic usage after using this medication. However, in, the study or in the discussion, getting that statistical difference in this particular study with such a low number of participants and all the problems we had with executing this study is sort of a statistical reach. You know, some statistical manipulation was done so that we could reach a statistical significance. And when conversing with my colleagues and every that was involved with it, you know, we felt like maybe that's not a really a clinical relevance. So, we were a little disappointed with that. But we were also disappointed with some of the choices we made in doing the study. You know, we had a lot of limitations. And if we could go back and redo this, I mean, that's probably what every researcher looks at after they get done with something like that, then you'd do it a different way. But you know, it is what it is and I think it was worth putting out there, right? So, other people could stand on that shoulder and do something better. But I think we're all still hopeful that some method of this liposomal bupivocaine will be very useful and impactful to our profession.

Host: And do you think by utilizing liposomal bupivacaine that will lessen the perception of OMS and dentists over prescribing narcotics?

Dr. Jeffrey James: I think that it has a lot of potential. I really do. Now, fighting that stigma that's been generated over decades, I don't know if we're going to change the world with one technique change, right? But, you know, I'm in a dental school environment. But I got to say, over the course of just when I was in dental school versus how we're teaching students now, we use less narcotics a lot. I mean, that's a significant difference from when I was in dental school. And the standard of prescribing patterns over the course of whatever it's been, 20 years or whatnot, is significantly different. And I think it'll continue to change.

Host: Yeah, absolutely. Well, thank you for that. And Dr. Ferneini, I want to bring you in. Can you explain the relevancy of this research to the specialty?

Dr. Elie Ferneini: Thank you, Bill. This study really shows that using longer acting local aesthetics such as bupivacaine, where you use either liposomal or just a standard bupivacaine, can help with post-op pain control and also with decreasing opioid use, which is very important for our patient population. And a regular oral surgeon uses bupivacaine during his third more extraction, this will ultimately decrease the consumption of opioid use and also would have patient having better outcomes overall.

Host: Well, that is always important and that is something we're always looking for, is better patient outcomes. So, how can the average OMS apply this research to their everyday practice then?

Dr. Elie Ferneini: As Dr. James said, the goal for us, and it's amazing what he said about how when we used to be in dental schools 20, 25 years ago versus now, we've really have decreased our opioid consumption to our patients. So the same thing, the regular oral surgeon taking out third molars should somehow use longer acting local anesthetics, such as bupivacaine to decrease the postoperative pain control for his patients or her patients. And also, this results in decreased opioid use, improved patient outcomes and better patient satisfaction.

Host: Dr. Ferneini, thank you for that. And Dr. James, as we wrap up, thank you for your time. We appreciate it. Anything else you'd like to add to our discussion today?

Dr. Jeffrey James: You know, in my study we were trying to prove how effective it could be or whatnot, and we fell short of that. So, I would want the reader to approach this article with an open mind and recognize the design limitations in the way that we had to conduct it in a resident program. And the technique, I would encourage our private practice providers out there to try this technique, improve upon the technique. Because I can tell you as a, young researcher and academician, I love going to AAOMS in our meetings and talking about their techniques, and I get a whole lot of ideas to designing a study based on that anecdotal, conversation that we have at these meetings on, "Hey, I tried this and this really worked," and things like that. And so, that really helped fire up sort of our research brain on how we can get to the bottom of what's working, what's not.

So, the point is that, although I was disappointed in the results of the study, I still think liposomal bupivacaine has a huge future in our specialty. I think we just got to think about the technique, right? To think about how we're delivering it and how we can get more hard tissue anesthesia as opposed to local infiltration technique that we used in the study. And then what's been used thus far in all of four studies of OMS with liposomal bupivacaine.

Host: Yeah, that makes sense. Well, Dr. James, thank you so much for your time today. We appreciate it. And Dr. Ferneini, let me ask you the same question. Anything you want to add?

Dr. Elie Ferneini: Like Dr. James said, I think we're always looking for evidence-based data. And like he said, all of the study showed some results. I think that shows some promising results that liposomal bupivacaine could be really helpful in our specialty, or even using standard bupivacaine for our patients could help them as far as better pain control and less opioid use. But again, as our journal says, we're always looking for evidence-based data to help with our patients.

Host: Absolutely. Well, you can check it out. The study was recently published in the Journal of Oral and Maxillofacial Surgery, titled Pain Levels Did Not Differ Following uncomplicated Third Molar Extractions Utilizing Liposomal Bupivacaine Versus Standard Bupivacaine. Dr. James, thank you so much for your time. We appreciate it.

Dr. Jeffrey James: Thank you, bill. It's been a pleasure.

Host: Absolutely. And Dr. Ferneini, thank you for your time. Much appreciated.

Dr. Elie Ferneini: Thank you both. Thank you.

Host: Absolutely. And once again, that's Dr. Elie Ferneini and Dr. Jeffrey James. For more information, visit aamos.org/joms, that's J-O-M-S. And for the full podcast library, please visit aamos.org. That's A-A-O-M-S.org. And if you enjoyed this podcast, please share it on your social channels and be sure to subscribe so you don't miss an episode. Thanks for listening.