Opioid-Sparing Orthopedic Surgery: Evidence & Experience Based Discussion

Speaker 1Good morning, good afternoon and good evening. Welcome all of you to this live program at Orthopedic Principles. Today, our guest of honor is Doctor Scott Sigman from Massachusetts, United States. Doctor Sigmund is a national and internationally recognized leader in opioid sparing Surgery. He's an orthopedic surgeon that specializes in the Knee and Shoulder. He's been in clinical practice for over 25 years and is a leader of professional education, medical device development, and has numerous peer-reviewed public.

Speaker 1He's a team physician at the UMass Love. He's a member of the Governor Baker's commission to establish a Pain management access program in the Commonwealth of Massachusetts.

Speaker 1He did his Sports Medicine fellowship at the prestigious Cul and Job Clinic in Los Angeles. His opioid sparing Leadership propelled him to become a Fellow of the World Society of Sports and Exercise Medicine, and most recently has had the honor of becoming a Fellow of the Royal College of Surgeons in Ireland.

Speaker 1In addition to his clinical responsibilities, Doc Sigman is the Chief Medical Officer for Ortho Laser Orthopedic Centers.

Speaker 1The Arthur Laser franchisee was developed to provide an alternative treatment option for acute and chronic Pain to help combat the opioid crisis. Doctor Sigman is also the host of the very popular Ortho Show podcast. So today it's my great honor to introduce you to Doctor Scott Sigman from Massachusetts, United States. Over to you,

Speaker 1Doctor Sigman.

Speaker 2Thank you so much. What a wonderful introduction. I tell you, my mother's gonna be very proud when she hears that. So, thank you so much. It's a pleasure to be here for orthopedic principles. Uh, we're gonna talk today about opioid-sparing Orthopedic Surgery, evidence-based versus, uh, experience-based discussion. Uh, I like to describe myself as the original opioid-sparing orthopedic surgeon, healer of knees and shoulders, left and right, #follow the fro, and

Speaker 2Uh, also, you can see here my Other titles as well. So, it's a pleasure to be here. Uh, we're gonna walk our way through. You can see here in my disclosures, uh, for my consulting agreements as well. So,

Speaker 2Uh, clearly, the opioid crisis really started in the United States, and, and for a long time was a uniquely American phenomenon. However, I do think it has now spread across the world, uh, for the, the highly addictive opioids that are available, uh, for our patients. And, you know, upwards of maybe even 5 or 6 years ago, if I was not writing a prescription of opioids to my patients, uh, I might have even lost my medical license or gone to the Board of Registration of Medicine for, for negligence, for

Speaker 2For not treating my patients. But that pendulum has completely swung now in the United States, and the US Attorney General, uh, for the, for the United States sent out letters to alerting opioid prescribing Practices to doctors that were overprescribing. It was really quite a serious warning. And, and not only that, but this is a doctor that Practices in my local community.

Speaker 2Uh, he was actually indicted for involuntary manslaughter in the death of one of his patients who had an opioid overdose that was attached to his DEA number. So, uh, this is a serious problem at this point. We've created this horrible crisis, uh, of epic proportion, and really the onus is on us to really sort of change the paradigm of post-operative Pain management, minimizing opioids, you know, if at all possible for our patients. And this is ultimately what we're trying to achieve here, right? Uh,

Speaker 2This is a patient, uh, who's undergone an ACL reconstruction, quadricep tendon autograph, which is typically a very painful operation. He's sitting there sipping a soda on his cellphone with his parents by his side, and this is our ultimate goal, cause this patient in particular, has a very high percentage of opioid addiction, and many of these patients that basically underwent ACL reconstruction succumbed to opioid addiction, and, and many of them actually died from heroin overdoses because heroin became a cheaper option for these patients.

Speaker 2Uh, again, uh, you can see here, uh, again, opioid-sparing Surgery matters to patients and their families. This is a, uh, elderly gentleman who has undergone a Total Knee Replacement Surgery. He is approximately 10 days out, uh, from his Total Knee Replacement Surgery, and you can see here, uh, he's very comfortable. He's walking and ambulating without assisted devices. Uh, we're gonna talk today about the very specific things that we can do. His, his flexible range of motion is really pretty impressive for 10 days out.

Speaker 2And hopefully, he won't uh trip here and fall with his flip-flops, but you can see, uh, this gentleman took no post-operative opioid pills, only what was, uh, pres prescribed for him in the, in the hospital setting. So, really remarkable results. We can actively take our patients through Surgery now, minimizing their exposure to opioids and still getting really tremendous results. And so, in the United States, for example, you know, the, the cost of the opioid epidemic has been just dramatic. Uh, we're talking loss of life, loss.

Speaker 2Productivity, excess healthcare, just billions and billions of dollars that have been spent on the backside of this epidemic. Uh, in Massachusetts in particular, you can see here in 2017, the absenteeism from, from work, and the, and the patients that were, or the people that were at work weren't very productive. Uh, the overall cost to treating patients with substance use disorder to the state, the communities and the police officers who were required to be able to, um, provide Narcan for

Speaker 2Overdoses, as well as the excessive emergency room visits and ICU patient admissions as well. It's really just incredibly expensive, both in money as well as the, the loss of lives associated with this epidemic. So, uh, we really need to be active in coming up with a process to get our patients safely and effectively through Surgery. And what happened was, the operating room became an inadvertent gateway to the opioid epidemic. I've been doing this for nearly 30 years, and I was told, you're an orthopedic surgeon, what you do hurts.

Speaker 2Uh, patients are gonna be in Pain, and you have a responsibility to make sure that patients are out of Pain. You're gonna use these opioids because they're inexpensive, and they're really not very addictive. But both of those things, when you add up the overall cost of the epidemic, could not be any further from the truth. So, this is an important slide, one of the most important slides on the deck, and this is from the MMWR. Basically, this is a, a weekly report that comes from the Centers for Disease Control in Atlanta for CDC.

Speaker 2The gist of this is that if you take a look at this graph and this curve, there are 3 sort of entry points that happens where you get sort of an exponential acceleration of opioid addiction. And I'm gonna give you basically three numbers, 6, 13, and 30. If you prescribe 24 hours of opioid Pain relievers to 100 patients, literally 6 of that, 6 out of 100 will still be on opioids at 1 year. If you provide them a 10-day course of opioids.

Speaker 2Literally 13 out of 100 of those patients will still be on opioids. If you give them a month-long supply, nearly 1/3 of those patients will also still be on opioids at 1 year. Opioids are tremendously addictive.

Speaker 2We need to minimize our exposure. As of this moment, we don't have a DNA marker to find out who is going to be those, those brittle patients that become addicted. So, Opioid stewardship, you need to use opioids in the perioperative window, but how can you do it successfully and then use Other opioid alternative treatment options as well. And here in the US in particular, the patients are just fed up, and they, they all know someone that succumbed to the epide

Speaker 2Pandemic, and really, they're looking for uh options for treatment, and they'd rather really not even undergo Surgery, much less take the opioids. So, it's really important on our part to be able to help out. Every major medical society at this point has also uh thrown their hat in to say that opioid, the opioid epidemic is a severe public health issue, and we have a responsibility to, to care for our patients.

Speaker 2So, it's time for a change. What can we do? And we're gonna talk today about some experience and moving from experience really to evidence-based Research to show that we can minimize opioids and still safely and effectively take our patients through Surgery. And I'm gonna give you very specific things that we're doing in clinical practice right now, that help us to get through that process.

Speaker 2So, Zeb Kain is an anesthesiologist out of the University of California, Irvine. He came up with the concept of the perioperative surgical home. What does that mean? He takes all the players in the room, whether it's the nursing staff, the doctors, the administrators, uh, the secretaries, everyone that has a touch point to a patient in the surgical intervention, comes into a room and they talk about a team Approach as to how they're gonna manage.

Speaker 2To their patients. All members of the team are involved. It's to identify the Pain points in the process, and then figure out a solution for those Pain points, and then all staff is gonna convey the same message. What I'd like to say to my nursing staff and team is, remember, the Knee and Shoulder is attached to a person. We need to talk to the person, communicate with them, and make sure that the entire staff is communicating the same message. It does no good if you're gonna give an extended long

Speaker 2Term nerve block for Upper Extremity, to have a nurse say, well, when the block starts wearing off, you can take opioids, because they just don't need them. And so, uh, kudos to Zve Kane and his troop, uh, for coming up with this idea, of the, of the peri-surgical home. This is an interesting study from Asif Ilias. The, uh, the Rothman Foundation in Philadelphia has now become one of our, uh, country and international leaders in evidence-based Medicine for, for opioid Research. So, the Rothman Opioid Foundation in particular.

Speaker 2This was a Carpal Tunnel study, and uh what Doctor Elias did was he basically uh operated on a bunch of people with Carpal Tunnel. He gave them all the same narcotic or opioid prescription. He talked to half of them about the idea of reducing the need for

Speaker 2For opioids, cause you don't need to take them and did not talk to the Other half. And that simple communication of talking to the patient reduced overall opioids by 30%.

Speaker 2So, communication with your patient is huge. It starts in the office, it goes to the preoperative holding room, it goes to the PACUA recovery area, and then the discharge nur nurse is also providing the same information, and then you call the next day. And all of that will help to communicate to the patient to make sure that they understand the successful outcome of minimizing opioids. This is uh something that we should have done a very long time ago. I've been doing Knee arthroscopy for over 30 years, and still, what would we do? We give

Speaker 230 to 40 pills for patients to go home with for narcotics for a routine Knee arthroscopy. Well, you can see here the group out of Detroit that did this multimodal non-opioid Pain protocol clearly showed through a randomized controlled trial that opioid, uh, opioids are not needed for a standard Knee arthroscopy, that patients will do just as well without opioids as they do with. So again, now we're moving into not just what's been passed down to us, but actually evidence-based Medicine with randomized control.

Speaker 2Trials. Here's the multimodal Approach which most of us are familiar with. We can attack Pain from a lot of different areas across the blood-brain barrier, into the, into the, to the brain, for example, with new receptors and opioids and alpha-2 agonists. We can then modulate at the spinal cord level as well. There's new receptors there as well. We can also

Speaker 2To do peripheral nerve blocks or spinals, where we're gonna block transmission with local anesthetics. And then we can also reduce prostaglandin mediated inflammatory reactions with non-steroidal anti-inflammatories at the level of the skin where the incision is going. So, so for me in particular,

Speaker 2It's loading up my quiver with as many hours as I can that will provide this non-opioid relief. When they all add up together, is where we get the successful model where we can really minimize opioids. So, opioid sparing preoperative solutions. What are the things that we can do preoperatively to help with our

Speaker 2Patients. We're gonna talk today about temporary cryoaoneommesis, which is a new device, uh, which we are using routinely now in the perioperative window. Certainly, perioperative regional nerve blocks, whether it's a scaling block in the Upper Extremity or canal blocks down in the lower extremity. Sublingual opioids, which is a new medication that was FDA cleared here not too long ago, which is a real fascinating medication, which we'll talk about in detail.

Speaker 2Uh, big believer in COX-2 selective non-steroidal anti-inflammatories, both oral and there now is an IV preparation, where we're having great success. Please do not forget about Tylenol or acetaminophen. We use it orally, uh, routinely with a prescription for our patients, whether you use it IV or not. And again, most importantly, patient communication. So, intraoperative solutions, what do we have?

Speaker 2Available. Certainly the regional blocks such as spinal epidural. Local anesthetic infiltration has always been a mainstay of surgical intervention. The problem has always been the length of time in which it works. We'll talk about that as there are some newer medica.

Speaker 2Patients that provide longer relief, and we talked about the COX-2 selective IV non-steroidals as well. And now, postoperatively, what I'm doing here is I'm actually listing for you my active prescription protocol for our patients that we provide for them when they head home after their surgical intervention.

Speaker 2We all know that Tylenol works. The problem is if you say to your patient, just take Tylenol, they think it's over the counter, they think it's voluntary. Absolutely not. 1000 mg, basically every 8 hours, 4 or 5 days to be able to prevent Pain, really makes a difference. We write an actual prescription. We use gabapentin 300 mg at nighttime for Pain relief, also to help with sleep. Meloxicam is a COX-2 inhibitor for 5 days as well as an excellent uh Pain reliever and anti-inflammatory, and then short-acting opioids for breakthrough Pain.

Speaker 2Clearly communicating to the patient, that it's OK to have a mild to moderate amount of Pain and discomfort. If you can get on your cell phone, if you can read the paper, if you can talk to people, that Pain level is reasonable. It does not have to be zero. Most patients are appreciative of that conversation.

Speaker 2So, how do we get here? This is a patient that had a Total Knee Replacement at 7:30 in the morning. She's now heading home from our Surgery center at 10:30 a.m. She's got a smile under the mask. She's walking out with a walker without a perceptible limp, and not having any Pain. This is where we are. In the United States, since the Pandemic in particular, there's been a huge push into the ASC model. The patients don't wanna go to a hospital where they're sick patients, they wanna be done in an Outpatient center where it's

Speaker 2Clean and healthy. Uh, and the estimate is by 2024, by the end, nearly 80% of orthopedic surgical interventions are gonna be done in the Outpatient center. So, we're big believers in

Speaker 2Uh, you can't just send the patient home because it's the same day. You gotta make them comfortable, and that's what we're gonna talk about here. So, opioid sparing preoperative solutions, let's talk about nerve blocks. So, in particular, ayoe vera, which is known as a preoperative temporary cryoacinommesis device. This is the liquid nitrous oxide device that circulates liquid, liquid nitrous nitrous oxide through the, uh, through the system of the actual instrument, uh,

Speaker 2That actually never gets into the skin, but we'll show you. It's a simple percutaneous treatment, immediate, safe, and effective, non-systemic, long-lasting nerve block upwards of 3 months. It's a temporary axoneommesis. We're not burning nerves. There's no, uh, ablation of nerves. Also, it's also clear to, for the treatment of Pain symptoms of Osteoarthritis. We

Speaker 2Use it routinely in the perioperative window. You can see here, here's the device over in here. The treatment creates a cold zone, lowering the temperature to below about 20 degrees below Celsius. You get Wallerian degeneration of the axon and the myelin sheath, which temporarily blocks the nerve signals. And then over time regeneration happens as we're familiar with all nerves, about 2 weeks to get started, and then about 1 to 2 millimeters per day. And at the end of

Speaker 23 months, you have complete reinnervation. So, no ablation, but what happens is, you're ablating the anterior femoral cutaneous nerve and the infrapatellar branch of the saphenous nerve. Both are cutaneous nerves. There's no motor block. These patients have complete control of their leg, but they don't get the stretch skin Pain associated with Knee Replacement that many patients have a hard time breaking through to regain range of motion.

Speaker 2So you can see here, this is a multi-centered uh prospective sham controlled double-blind study across 17 sites. Uh, the treatment group was 121 patients that were treated with Ayoe vera. The control group was treated with a

Speaker 2A sham tip, and basically, the Womack Pain scores were significantly reduced at 30, 60, and 90 days for the patients in this study. So, solid evidence-based Medicine again, demonstrating the positive effects of an opioid alternative in the setting of our patients. And now, this ayour vera treatment for me in particular, my clinical practice has become a mainstay. We will do this about 7 days prior to the intervention of the total Knee. The patient comes in, they sit there.

Speaker 2For about 30 minutes for the actual process. They get up, they walk out, and they get immediate relief, many of the patients immediately after the treatment. And the reason we do it a week in advance is cause we know it's gonna last for upwards of 3 months. So, you can see here again, uh, this is the reduction of the WOMA scores that we were talking about, uh, with P values that are quite significant for 30, 60, and 90 days. So, preoperative regional upper

Speaker 2For extremity blocks. What are your choices? A single-shot interscaling block with anesthetic or a continuous catheter interscaling nerve block, both of which are used routinely here in the United States. So, the single-shot interscaling block, what's the pro? Well, no patient monitoring. Uh, it's a long-acting anesthetic.

Speaker 2That can be provided to provide patients a soft landing and the the analgesic effect of this uh nerve block can last up to 5 days. The cons are basically, the shorter-acting anesthetics wear off with rebound Pain at the worst possible time, within 12 to 18 hours. So we strongly recommend using the longer-acting anesthetic, and we'll discuss that. And then the cost of the long-acting anesthetic, some people argue, adds to the cost of the intervention. The continuous catheter.

Speaker 2For interscaling nerve blocks, the pros, you can get 3 days' worth of Pain relief, reduction in opioid requirements. The cons are that anesthesia needs to monitor this, uh, in the Outpatient setting, and there are excessive costs associated with the use of that, uh, uh, uh, system as well. And the patient maintenance of the counter of, of the catheter will oftentimes move and have to be adjusted, generating significant

Speaker 2Calls uh for uh management. So, local anesthetics for regional blocks, reliable local regional anesthetics for Pain control, the problem has always been the limitations, which are the duration of action. So, liposomal bupivacaine is now on label use in the United States by the FDA for interscaling brachial plexus nerve block. So, this provides prolonged Pain relief, upwards of 4 to 5 days. It's a single dose administration, which is done under Ultrasound guidance by the anesthesiologist in the holding room prior to Surgery.

Speaker 2This requires 133 mg uh dose, which is about uh 10 cc vial at this point. And the overall cost of this is about $150 US. uh, and then over the age of 18 are the uh FDA indications. This is the FDA pivotal trial that was done, uh, proving, uh, the safety and efficacy of the single-shot interscaling block with liposomal bupivacaine. You can see here that the

Speaker 2sensory block, uh, would last typically up to about 36 hours, and the motor function usually comes back within 24. So, within 24 hours, they're starting to get motion and movement back, they get still some numbness and tingling after 36 hours. And in my personal experience, in my clinical patients, uh, patients are getting Pain relief up to 3 to 5 days. And now, most of my arthroscopic Rotator cuff repair surgeries are now done opioid.

Speaker 2Free. Really has been one of the most dramatic things that we have done in changing, um, Upper Extremity Surgery, which has always been routinely one of the most painful surgeries, uh, because of, uh, all of the nerve endings around in the area, and so great success with that.

Speaker 2So here's a non-industry liposomal bupfecanine brachial plexa uh block here you can see here. Basically they

Speaker 2They basically did a, a, a comparison of a liposomal buppivicaine, uh, brachial plexus block versus, uh, a placebo effect, and then they evaluated the patients for, uh, opioids, uh, opioid rescue, Opioid Free patients, etc. with significant reduction, uh, in Pain scores, as well as overall opioid consumption, and a much increased percentage of Opioid Free patients. So, uh, this was a trial again outside of industry. Here's another non-industry, uh, study here specifically looking at

Speaker 2Single-shot brachial plexus block versus continued catheter, and they are showing equivalence in Pain relief between the two. So, in this situation, this gives us license to say, why not do a single shot. It's less expensive, it's less labor-intensive, does not require the significant monitoring associated with that. So, even some of the most uh uh skeptical doctors that were worried and concerned about a long-acting block for the Upper Extremity have now transitioned in because of this study in particular.

Speaker 2Uh, as well. We'll skip this slide here. Um, but, so, preoperative lower extremity regional blocks, what's available? The IPAC block and the adductor canal block. So, let's talk about each of those. So, the IPAC is an infiltration between the popliteal artery and capsule of the Knee. It's a technique that's done under Ultrasound guided typically by the anesthesiologist, and it goes between the inner space of the popliteal artery and the capsule of the Knee.

Speaker 2So, in particular, Knee replacements have tremendous amount of posterior Knee Pain because of the process. So, you either need to do a local infiltration of the posterior capsule at the time of your Total Knee Replacement, or you have the anesthesiologist do this IPAC block before. Uh, uh, it is off-label use for liposomal buppiviccaine, but many of the anesthesiologists are using that. Again, providing significant longer-term Pain relief for that posterior Knee Pain. And then the adduct canal block was really was really brought because of the concern for femoral nerve blocks, where we would get significant

Speaker 2Uh, uh, loss of motor control. Obviously, these patients would then have traumatic injuries. There was a lot of wounding hissance, a lot of falls, uh, and so, this is now a pure sensory block that happens adjacent to the femoral artery in the saphenous vein and really provides significant medial-sided, uh, Pain relief and allows quadricep function to be maintained. And the same goes for liposomal bupivacaine can be used, but it is off-label.

Speaker 2So, opioid-sparing solutions. Let's talk about preoperative medication, what's available. So, again, I really like to bring up Tylenol. I think there's great benefit from Tylenol. Uh, this is a recent study that was done, uh, again, out of Rothman, one of the great leaders again, uh, for opioid-sparing evidence-based, uh, Surgery. This was a, a study specifically looking at arthroscopic Rotator cuff repair. There were 3 groups. One of the groups

Speaker 2Groups was getting only opioids. The next, uh, group was getting both Tylenol and opioids, and then the final group was only getting Tylenol. Uh, and basically, uh, you can see here, this is the, the dosage that was associated with the use of Tylenol through, uh, day 5. And, and Tylenol wins on, on all of the accounts here as far as the reduction in need for opioids in the post-operative setting. So,

Speaker 2Patients are satisfied with Tylenol, they're getting Pain relief, and they can then minimize opioids. So, as far as I'm concerned, uh, oral Tylenol, unless there's a contraindication from hepatotoxicity, is something that should be absolutely part of your perioperative, uh, protocol for Pain relief.

Speaker 2So, Opioid stewardship. This is a new concept, something that we've been talking about, because at the end of the day, opioids are still typically used at the time of anesthesia. They're used for, uh, for anesthetic induction. Typically it's 100 100 mcg of fentanyl, and then they're also getting significant doses of IV, uh, opioids.

Speaker 2In the recovery room setting as well for patients that are having breakthrough Pain. And so, the concept is, can we come up with a better way of doing that, where we can potentially still provide opioid, uh, Pain relief or induction at the time of anesthetic, but perhaps we could reduce the overall amount of opioids that are used in the intraoperative setting, which would then translate to the perioperative or postoperative setting as well. So, what is Opioid stewardship? It's a strategy that was published by the National Quality Forum in 2018.

Speaker 2It's really about the idea of, of management of complex Pain, both acute and chronic, understanding the pharmacology and the use of safe opioids, uh, usage. Basically, there are a number of issues, clinical knowledge, expertise, and practice with opioids, all of which will fall in. So, uh, at the end of the day, repeated dosing of IV opioids is really the current standard of perioperative Pain control by anesthesia. And I ask this question routinely to anesthesiologists, why are you doing an opioid induction?

Speaker 2You know, with 100 mg of IV fentanyl, because they may have Pain as they're moving over, etc. all of that, but it's really not it's not really evidence-based as to why they do.

Speaker 2So it, it's really more experience-based. It's been what they've been taught, and they continue to do it. The problem with the IV opioids in particular, is they can exacerbate cognitive problems that makes longer time in the recovery room. They can have respiratory depression, hypotension.

Speaker 2Uh, time-consuming in the PACU where the, the nurses are spending significant amount of extra time because they need to be available for mandatory observation periods, and that can be costly to the process. So, if we can come up with a strategy to use opioids, but perhaps minimize some of those opioid-related adverse events, ultimately, that would be ideal. So, I

Speaker 2Fentanyl is the most commonly used intraoperative medication, the PACU, and has a very rapid onset of action. It does not have active metabolites, but the problem is because it's so rapid in onset, it also goes away very quickly. So, more often than not, multiple doses have to be given, all of which start using up the new receptor, and then the argument is, is that the new receptors get up regulated to be able to accommodate the, uh, fentanyl dosing, and then it requires even more opioids postoperatively to satisfy the new receptor requirement.

Speaker 2So, morphine milligram equivalent is a way to be able to identify and look at different opioids and compare them equally across the board. So, you can see here, um, sublingual, uh, Sufentanyl tablets is what we're gonna talk about next, has a morphine equivalent of about 5 mg. And then IV fentanyl, which typically on induction is about 100 mics, is about

Speaker 210 morphine equivalents. So as you start adding up this morphine equivalence, that's when you start getting these additional opioid related adverse events. So, the question is, is there a better perioperative opioid choice? And the preoperative medication we're gonna talk about next is Sufentanyl sublingual tablets.

Speaker 2Now, it's really interesting, this medication was actually designed with the Department of Defense and the military, because many of our military uh uh trauma victims were getting uh the standard morphine into the thigh area in particular. The problem is when they were going into shock, they would not get circulation back to the core. They get them onto the helicopter, they'd warm them up, and then they get this blast of opioids that come back into the system and they have opioid overdose.

Speaker 2So the concept here is to use the carotid, uh, circulatory system, uh, and then you put this Tablet underneath the tongue, uh, and then it will dissolve. It gets directly into the blood-brain barrier, heads right into the brain, and then it creates immediate, uh, uh, Pain relief for, for these patients, especially, you know, in the traumatized patient, and that's when it moved over into, uh, to our world as well. So, you can see here, it dissolves in about 5 minutes. It's given only in a hospital setting. You cannot get this medication outside of a hospital or ASC.

Speaker 2It's not available for, for prescription or dosing outside of the center. Uh, the anesthesiologist administers this, uh, and then basically, uh, because the Sufentanyl has significant reduction in GI bioavailability, uh, we're skipping the GI tract by doing this, and it dissolves directly into the bloodstream. Uh, so, really quite a fascinating medication. Um, you can see here, it

Speaker 2It's much more potent than the Other, uh, uh, available narcotics that are out at this point, uh, which is scary, and you say to yourself, you know, Doctor Sigmund, you describe yourself as an opioid.

Speaker 2It's sparing, you know, orthopedic surgeon, why are you using this incredibly potent opioid rather than using something that's less? Well, because it's the way in which it behaves, the way in which it gets into the brain.

Speaker 2Brain, uh, it has a very unique, uh, uh, PK curve, which we're gonna show you. You can see here, this is the typical opioid adverse events that you can see here, uh, when looking at the sublingual sufentanyl tablets compared to the placebo. Very similar, uh, adverse events, uh, versus placebo effect here. You can see here when it comes to respiratory adverse events, there was a slight bump up using, obviously,

Speaker 2The, uh, Sufentanyl versus the placebo. But the most important thing is that none of these patients required a lo naloxone reversal. So, yes, there was some, uh, clinical respiratory depression that was identified, but not enough to create any significant, uh, clinical outcome change. So, here's the PK curve, and this is what I'd like to show because I think it's really quite fascinating. If you look here to the red, that's the IV fentanyl. And you can see that they give the 100 mics or so in the operating room, and it goes up quick, and then it goes down right below the analgesic threshold.

Speaker 2And then, what happens, they have to get more medication into the PACU as the patient rolls in. Uh, and so, what happens is when that happens, it keeps using the mu receptors, and when then that typically up-regulates them as we talked about. Now, you can see here with SST or the sublingual, you can see it's a much

Speaker 2Bladder PK curve. Not only that, it actually has a, uh, stays above the analgesic threshold for 3 hours. So you give this patient a sublingual Tablet below their tongue. They go undergo their surgical intervention, an ACL or a Total Knee Replacement or Shoulder, whatever it is that you're doing. You know, Surgery takes 1 hour, you know, maybe 90 minutes, and then they will.

Speaker 2Go to the PACU and they're still getting Pain relief from the sublingual Tablet without having to get the IV. So, what we're doing now is providing only the sublingual Sufentanyl. We're now avoiding the, the, uh, perioperative IV fentanyl, not giving fentanyl an induction. We're not giving fentanyl IV dose into the PACU, and, and the results are really quite remarkable. We're actually reducing the overall amount of opioids, as well as the time in the PACU. You can see here, one of the Other things that I really like about this medication.

Speaker 2is that you don't get cognitive impairment with it. So, even in the elderly population, they're not going loopy as they typically would with IV fentanyl, where they pass out or, or go to sleep. They basically have the steady state, they're still able to communicate, and they're able to, to maintain cognitive uh uh understanding.

Speaker 2So, let's talk about evidence-based support for this. So this is by Doctor De Wettenstrand. It's reduced opioid use and time in the operating room. This was done as a, as a historical control, uh, study, cohort study here. But you can see here that the post-operative opioid use was dramatically

Speaker 2reduced. Overall opioid consumption, uh, basically went down by about 50%, which is really impressive. And you can see here, overall morphine equivalence, uh, con uh con uh, against the standard mean, uh, was also dramatically significantly reduced. So, we're using a more potent opioid that has a, just a better PK curve, which translates into less opioid-related adverse events.

Speaker 2Less need for overall opioids, and then also less time in the PACU, that you can see here, cutting the PACU time by about 20 minutes. If you're in a busy ASC and you're trying to take care of multiple patients, the less time in the PACU is very favorable. Another study here by Casabal, non-industry sponsored, taking a look at the same medication, again, confirming the reduction in overall postoperative opioid use uh by

Speaker 2It's by p values of 0.001, and then again, reducing recovery room uh time as well. So, you know, pretty fascinating medication, one that I'm currently involved in a Clinical Trial for ante cruciate ligament repairs as we speak, and the initial results have really been quite profound, uh, so we're

Speaker 2Very excited about this medication as being part of our pro forma for how we treat our patients. Next in line is the preoperative or intraoperative use of a COX-2 selective non-steroidal anti-inflammatory. This is the first of its kind, uh, non-steroidal anti-inflammatory IV preparation for meloxicam.

Speaker 2So, it's 24 hour Pain relief with a single IV push dose of 30 mg. It has demonstrated safety and efficacy. Cox-2 preferential intravenous non-steroidal is super important when you're deciding which anti-inflammatory you're gonna use, and it's a once daily IV push that's given by the anesthesiologist, typically in the room, uh, at the time of surgical closure.

Speaker 2So, you can see here, this was a, a randomized controlled trial, placebo, IV meloxicam versus placebo effect here, monitoring for bunions over a 48 hour window, with a 31% reduction in overall Pain, uh, clearly statistically significant, uh, for patients as well as reduction in the need for opioids. So again, one more arrow in my quiver, working at a different place in a multi-modal program to be able to reduce Pain medica uh for our patients.

Speaker 2Now, COX selectivity is super important, and so you can see here where meloxicam falls, which has, you know, a more COX-2 selectivity than COX-1. The medication that's most routinely used in the United States right now as an anti-inflammatory, is ketorolac.

Speaker 2And I would make the argument that yes, it's an anti-inflammatory, but is it really the correct anti-inflammatory to use? It's mostly COX-1 selectivity, which we'll talk a little bit more about, and it only works for 4 hours. So IV preparation of of ketorolac lasts for 4 hours. Not exactly what you're looking for, for a more longer term, uh, Pain reliever, depending on your, your Outpatient.

Speaker 2Surgical intervention. I should also go back and say that the, the sublingual sfentanyl tablets have 3 hours above the threshold, but it's, the half-life is up to 13 hours as well. And this is an important slide because people get, I think, get a little confused about the COX-1 and COX-2, uh, receptor issue.

Speaker 2So, COX-2 selective receptors are really at the skin level. For example, you cut the skin, and what happens is you get uh an upregulation of the COX-2, which is a prostaglandin mediated inflammatory effects. So you get more Pain, you get inflammation, you get swelling, you get fever.

Speaker 2So, if you have a COX-2 selective blocker, then you're blocking Pain, inflammation, and fever. Now, COX-1 is very different. COX-1 is really on the endothelium, it's on the inside of the body, and it's a protective effect. So that when it's an upper regulation, the COX-1, your platelets work better, your gastric mucosal works better, your renal homeostasis is good. If you block the COX-1, you get platelet dysfunction. You can get GI disturbance and, and kidney issues.

Speaker 2So, if you're gonna use an anti-inflammatory medication, you're much better off in the Pain world of using a COX-2 selective, which is why, in particular, IV meloxicam falls into that window.

Speaker 2So, intraoperative solutions, what else can we do at the time of Surgery to help? Well, cer certainly, local anesthetic infiltration has always been a mainstay of surgical intervention. The problem has always been the duration of action. Uh, the volume distribution of where you're putting it is super important. You gotta make sure you get local anesthetic to all the nerves that have been disrupted at the time of Surgery, and I can't emphasize enough the importance of technique as to how you're using this medication in particular.

Speaker 2So again, liposomal buppiviccaine, we talked about it earlier for regional blocks. It's also indicated and FDA approved for the infiltration of surgical intervention for soft tissue and bone procedures. Now, the issue with liposomal bupfeccaine is that these liposomes have to be spread to everywhere across the wound, where you've had an injury to the nerve. So, what you have to do is you have to spread it. You have to admix and add saline to the area to make

Speaker 2Sure that you're going to get the liposomes where they need to go. In the adult population, you are not diluting your liposomal buppivicaine when you add saline, you're basically just allowing it to be spread out, uh, to more surface area. In addition, we typically will add a little buppivocaine, some free bviccaine, because it can take a little bit of time for the liposomal bvicaine to release. So we basically combine saline, we take the liposomal bvicane, we take some admix.

Speaker 2Uh, we take some free buppipicaine and then we then spread it out to make sure it gets to the appropriate area where Surgery is going on. The Other thing about liposomal buppivicaine is because of the liposome, it has, uh, the, the, the fats associated with it. It has more friction as you're injecting. So traditional buppivocaine, if you will, goes out to the size of a quarter, or liposomal buppiviccaine goes to a dime. So you have to make sure you're infiltrating the entire area in the appropriate fashion.

Speaker 2Uh, some interesting news that there's now a pediatric indication for liposomal buppivacaine in the United States, FDA approval for the age of 6 or greater. Unlike adults, weight based dosage is recommended.

Speaker 2So, in addition to not just sort of, you know, sort of guiding you as far as the amount of fluid, but we now have specific techniques that have been developed. Uh, this is a technique that I developed specifically for quadriceps tendon autographed ACL reconstruction. You can see here, we use 20 of liposomal buppivicane, 20. 0.5% buppivocaine, and 40% of saline. That gets us a volume of 80 ccs. And then you can see here, in a step by step process, we show you exactly where to inject. And when you do this, you

Speaker 2Really help to reduce the overall Pain associated with the surgical intervention, which allows these patients to get through the worst of it. I call it the storm of Pain, right? When you first take a knife to the skin or to the bone, it hurts tremendously. But after 2 to 3 days, it just doesn't hurt as much. And this long-acting anesthetic helps to get you there, uh, so these patients don't have that discomfort. You can see here, this is a technique for, uh, arthroscopic Rotator Cuff infiltration. If you don't have ultrasound-guided.

Speaker 2Uh, anesthesia around, you can still do this with success by doing your own, uh, infiltration technique. You can see here for Total Knee Replacement. Again, very specific intervention here, showing you the exact technique of how it's done, as well as the amount. Uh, and then again here, now, even for Hip fractures, we can now safely and effectively take our elderly through Hip fracture Surgery and uh undergo procedures without necessarily having to take opioids. So, really fascinating technique, one that's become a mainstay of our treatment. Now,

Speaker 2This may fly over the heads of some of the people that are listening today, but the literature itself, is it confounding or consensus? And so, in particular with liposomal bupivicane, there's over 1000 articles that have been published, and it's equally split on effectiveness. So, I like to say that that liposomal bupivicane is like the Grateful Dead and black licorice. You either love it or you hate it, there's really no in between.

Speaker 2So, let's talk about this. So, you know, as a general rule, we're taught, like, if there's a really good journal and it's been published and it's been peer-reviewed, it must be gospel and it must be the truth, and I therefore believe it. So, here's Paul Sete, who's an orthopedic surgeon, a well-respected, a member.

Speaker 2The Shoulder and Elbow Society, uh, who wrote an article published in their journal, where he looked at a randomized controlled trial for arthroscopic Rotator cuff repair. They did a neuro scaling block at the time, uh, liposomal bupivicane was not on label use yet for this type of block, so they did a standard bupivacaine block. And then they, they randomized it either into an infiltration with local anesthetic, which is liposomal bupivacaine versus not.

Speaker 2And they showed clinical and, and statistical significance with the reduction of opioids and Pain, uh, and really, you know, very positive outcomes. Then you move over, and then you have Sarenda Namdari, who's also from the Rothman Clinic, who publishes and, uh, you know, the JBJS, obviously again, another, uh, exceptionally reputable journal. He's looking at, uh, total Shoulder replacements.

Speaker 2And basically, they did the same thing with the, they use repivocaine instead of buppivocaine, and then they used a much smaller volume of the material of liposomal buppivicaine with saline. Uh, it was not validated as the specific process, and their results showed uh statistically significant higher opioid opioid use in the liposomal bupivicane arm, which is hard to understand, but at the end of the day, you know, Doctor Namdari is an outstanding orthopedic surgeon, as

Speaker 2This is Doctor Sehi, and they underwent, you know, similar process and came out with different results. So, which I think is really one of the most important issues when it comes to liposomal buppiviccaine, is having the appropriate technique. You've got to make sure that you're getting and spreading the medication where it needs to go. And this is another article or process within a Total Knee Replacement. So this was a cohort study from 2014.

Speaker 2And they took a look and did an Injection with liposomal bupivacaine. They only used a total volume of 50 cc's and the results were not very good. Basically, they were not able to show that there was any significant improvement with the use of liposomal bupivacaine.

Speaker 2So now you have uh Doctor Mont from 2018, who does a perspective randomized double-blinded study using 120 cc's of volume to make sure he gets it spread to all of the right places, and he shows a dramatic reduction in opioids, low opioid, lower opioid use.

Speaker 2Improvement in overall patient Pain as well. So, the message here loud and clear, just because it's in a journal, and it's written, and it's peer-reviewed, you still have to do your own analysis and your own evaluation to make sure that uh what you're, what is, uh, what's being read is reality and what you would recommend.

Speaker 2So, as we come to the close of the talk, you know, I think the questions that I'd like to leave everyone with is, you know, how are you confronting the opioid epidemic? What are you doing for your treatment Protocols right now to improve your patient outcomes and minimize opioid exposure? What are your tips for a multimodal Pain control? What are you doing? What medications, uh, what modalities are you using? Are you communicating with your team and staff? What are your challenges in reducing

Speaker 2In your patient's opioid consumption, it may not be that big of a challenge elsewhere around the world. It certainly is here in the United States, and I do believe it's becoming more of an issue. And then, uh, uh, you know, how do you introduce new approaches to your practice? How are you going to learn? How are you gonna learn new techniques so that you can safely and effectively operate on your patients, and hopefully get them through their surgical intervention without opioid addiction with a successful outcome. It's been a tremendous pleasure to be here today.

Speaker 2Hey, I thank you so much, as we say, #follow the fro, uh, and would love all, everyone to listen to the ortho show. We have remarkable orthopedic surgeons from around the world who tell their interesting stories. This is really not a technique-driven podcast. It's more about the remarkable stories of some of our great orthopedic leaders from around the world, and, uh, I know you'll like it if you do listen in all places that you listen to podcasts. Thank you so much.

Speaker 1Thank you, Doctor Sigman. Fantastic lecture. Very enlightening.

Speaker 1A couple of

Speaker 2questions. Yes, of course.

Speaker 1Uh, Doc Sigman, what do you think about a newer philosophy called the neuromodulation, where people are inject, I mean, they're looking at peripheral nerve stimulation for those chronic pains, especially those who come, say after 6 weeks or say after 3 months, or say after a year.

Speaker 2I think neuromodulation is absolutely innovative technique that's gonna become a mainstay of treatment for us, and I think that uh it might even actually be able to use in the perioperative window as well to perhaps prevent some of these patients from, from going on. I am

Speaker 2By no means an expert in neuromodulation, but, you know, the A fibers and C fibers and, and the differences that are there in the presence of, of this, but that's an exciting Technology, one that I am watching, uh, and anticipating really great developments.

Speaker 1Thank you, Doctor Sigmund for that. And uh what is your concern regarding the uh response of the articular cartilage to a local anesthetic? Do you think that is detrimental or what is a critical dose beyond which you think that a local anesthetic could injure an articular cartilage? For example, we, we have looked at uh papers from Frederick Matsen, Brian Cole, some of them have published chondrolysis, isn't it?

Speaker 2So, if you're old enough like me and have enough gray hairs, we all lived through the chondrolysis phenomenon from when we were putting in Marcaine directly into the joint with pumps. You know, the most recent pumps now are bathing nerves and not bathing the joint. And we saw devastating, you know, secondary events with, with complete chondrolysis and loss of the joint space.

Speaker 2So, most of us at this point are really not too keen about uh uh exposing our patients' joints to too much anesthetic. Uh, I use 0.25% Marcaine. I've been routinely using that for 25 years. I've seen no detrimental effects, uh, to that. I wanna be clear that the liposomal buppiviccaine infiltration that we are doing is not indicated to be in the joint.

Speaker 2We are not ever injecting liposomal bupivacaine into articular space. So, I think that, uh, moderate amounts of, of anesthetic in the setting of the perioperative window can be uh, you know, have a positive effect. I would clearly not recommend large doses or continuous, uh, uh, administration of, of, uh, anesthetics into joints.

Speaker 1Thank you, Doctor Sigmund for that. And what is your take on uh Other NSAIs like etodolac, which are also cox too? You've mentioned, of course, meloxicam. Do you have experience with etodolac?

Speaker 2So, so, Toradol or ketorolac is actually a COX-1, uh, uh, predilector. And so, uh, we feel that that is the wrong anti-inflammatory to use because of the fact that it's not creating a prostate gland and mediated response at the skin level. Uh, it only lasts for 4 hours. And so that my experience is that the IV meloxicam has really behaved much better, and from a pharmacological standpoint, seems to be a better choice.

Speaker 1And just one last question before we wind up the session. What is your take on some of the newer opioids? For example, tendedol is something that has been hyped up a lot, saying that it reduces dependence and all that. So what is your take on that?

Speaker 2Yeah, I mean, I'm, I'm a big believer in trying to minimize all opioids, you know, across the window. Now, why is it that I'm, I'm sitting here talking about sublingual Sufentanyl? Well, that's gonna be used in the perioperative window by anesthesia. That's not a medication I'm using in the post-operative window.

Speaker 2And I think we're demonstrating by the use of that medication, we're still reducing the overall need for opioids in the postoperative setting. So, uh, I am an opioid sparing opioid steward of all costs, not looking at this time for any new opioids in the post-operative window, uh, we're looking for opioid alternatives.

Speaker 1Thank you, Doctor Sigman. I think that's all the questions that we have for this session. Fantastic lecture, and I'm sure this lecture is gonna benefit a lot of people all over the world. Thank you so much for joining in, Doctor

Speaker 1Sigman. Oh,

Speaker 2it's been such a privilege to be on here. I really thank you so much for the opportunity.