A (6:05)
I have visited Madrid on various occasions. If you've never been, you really got to go. I mean, tapas galore. I mean, they like their pork, that's for darn sure. And a good Spanish red wine. I mean, it's amazing. Espana, Barcelona. You really should go check it out now before we get to that new study from Espana. So let's talk about a little reminder, just briefly, about what ACOG recommends. All right? Just briefly. Just as we recap this, because it's in the practice bulletin that we mentioned in the intro, which was 2, 2, 1. Now in that guidance it reminds us that while individual studies have shown greater success rates with regional anesthesia, there really isn't that much data to say that one is better than the other, meaning epidural or spinal. Although most people go the epidural route because if they place the spinal and then the physician gets called away or there's an emergency or whatever, you are on the clock for the spinal. Remember, one shot spinal, once that wears out, it's done. But an epidural, you can keep redosing the canister. Plus if you need to move to a C section after your attempt, the analgesia anesthesia will be more long lasting. So most people go for the LEA labor epidural anesthesia over the SAB spinal anesthetic block. But nonetheless, there's not a lot of hard data that one is better than the other. But without question, neuroaxial anesthesia plus a tocolytic agent increases success and makes the procedure much more tolerable. Okay, now that brings us to this Spanish study, the title of which is Comparative effectiveness of Intravenous Remifentanyl Epidural Anesthesia or a two step Analgesic Approach for External Cephalic version and a large prospective Single center Cohort study. End quote. So I think we need to pause here for just for a minute and discuss what REMIFENTANIL actually is because you know, fentanyl of course on the news and it should be on the news. Bad fentanyl, illegal or illicit fentanyl can kill you because it's done outside of a controlled environment. And literally micro gram amounts can be too much and if used either in the wrong context or with another agent. So fentanyl freaks people out. But remifentanyl, when used in the correct way is phenomenal, despite the FDA warning, which I'm gonna talk about in a minute. Now remifentanyl, of course has been, is already used in a lot of different labor and delivery units as part of a PCA system by name. Some people know that more as ultiva. I just comment REMI or remifentanyl. But it's so, so fast and it's very predictable in. And his metabolism is very quick, right? That's why people like it because it's up very fast action and it kind of goes away, goes away very quickly. It is ultra short acting. It is a synthetic opioid receptor agonist on the MOO receptor. And it's very, very rapid onset, short duration. But it does have the potential to cause some sedation. So this is abuse both intrapartum, intraoperative. Sorry, I lost my word there. Intraoperative or postpartum for pain control in the appropriate setting. Very, very potent. But the good news is that it's metabolized very quickly by plasma esterases, not by the liver. So it's got a lot of room for metabolism. That's why it's usually done by a pca, because it goes up quick and then it goes away very, very fast. Which would be fitting of course for an ecv because an ECV doesn't take forever, right? So over about, you know, a couple of minutes, you push a little bit of remifentanyl, which is micrograms per kilo per minute. And it really does work. Now there's different protocols. Some use anywhere as low as 0.1 micrograms per kilo per minute, some use 0.5, some use 1 milligram per kilo per minute, like a small little bolus. So whatever your hospital does, stick with that. As long as you have a proper protocol, anesthesia is aware and you maintain ot. These patients should have nasal cannula to keep their oxygenation up. And of course they need a pulse ox. All right, now remember, we're just on the reminder of what REMI is. REMI is only used for IV and it's slow IV push or on a pca. It's never used as a regional. It's not used as an epidural or through intrathecal routes. It is only meant to be peripheral as an IV push or through a PCA. Okay? And you've got to adhere to your PMPs and tell anesthesia about it. Some units, it's all written for and controlled by anesthesia. Sometimes the nursing staff does it by with pharmacy. Nonetheless, just be know what you're doing because it can cause the biggest issue, of course, is respiratory depression. Now, now, here's the catch. Even though we know this works, and I'm going to give you the data here, not just from this study, but multitude of ultra of other studies that say that remifentanil used correctly absolutely is effective and much more effective than other opioid options intrapartum, and it can help reduce a patient's need for epidural. I'm going to give you those studies in a minute. However, however, you guys got to listen to this. The FDA label for Remy is kind of scary. It's like, don't use, don't use intrapartum. And it's a big narcotic. And it passes to the baby. Yes, it can. Yes, it can cause respiratory depression in the child, especially if it's proximal to delivery, just like morphine can. That' not anything unique to remifentanyl. And plus, that's why we have Narcan. But it freaks people out because there is that FDA kind of warning, just like misoprostol had the warning, you know, against using pregnant women. And obviously that's a very effective agent for cervical ripening and labor induction. All right, My point is that sometimes there's a disconnect between clinical utility and FDA label, and those are two different things. Okay? So in this case, in this case, there's plenty, plenty of data that shows that there is clinical adoption and it's growing for intrapartum because it really does work astoundingly well for pain control. Well, I was going to do this later, but let's just do this now because since we're talking about its effectiveness and we'll get into the study from Spain. Okay, first of all, the respite trial. Okay, so R E S P I T E. The respite trial, this was back in 2018 in the Lancet. This was big, big, big multicenter. It was randomized, but it wasn't thousands of women. It had like 400 women, but nonetheless very well designed. The respite Trial showed that remifentanyl as a PCA or a patient controlled analgesia absolutely was effective in reducing the need for epidural rescue or a need to switch to another agent for intrapartum pain control. It worked. Women who received remifentanyl also experience fewer instrumental vaginal deliveries compared to like an epidural, which is very good because anytime that we can prevent, you know, potential baby morbidity with a vacuum or forcep and of course protect the pelvic floor, then that's a win. So the respite trial from The Lancet in 2018 said, look man, remifentanyl, I get it, it's a little scary because it's fentanyl, it can give you some respiratory depression. But just like fentanyl is used in the or, you can use that in a labor and delivery suite intrapartum with the appropriate safeguards. All right, plus guys, plus. In 2017, so just a year before the Lancet, there had already been a Cochrane systematic review of like 20 trials that had like 3500 women that found that remifentanyl PCA was in fact superior to other parenteller opioids with a relative risk of need for rescue of like 0.5. In other words, 50% of those who had remifentanil didn't need anything else. Right. Didn't have to escalate, didn't have to switch. That's really impressive. So we got the Cochrane review from 2017, we've got the respite trial in 2018 and nonetheless the FDA warning is like you do you doctors, nurses, midwives and the rest. But we're gonna stick with the label just to be careful. And I get that that's manufacturer protecting themselves, but there is absolute clinical utility and for Remy for pain control intrapartum. Now remember guys, our objective here is not to justify remifentanyl intrapartum as, as a pain control agent is about remifentanil for an ecv, which is what we are talking about in this episode. Pain control methods that is going to increase success. So you can flip that kid so he doesn't have to kick out the vagina, the labia, like saloon doors, like our comedian said in the intro. All right, so that's the end of our little mini review. Which brings us back now of course to the AJOG new publication from 3-5-2026 out of where, guys, where? Espana. So these authors did this single center, it was consecutive three phase cohort study and it included close to 2,000 singleton pregnancies who are undergoing an external cephalic version. So let's stop there for a minute. What is going on with Spain, man? I mean, how many breech babies are they finding in a. In a time frame? Amazing. This was between. Really? What was the years here? Yeah, it looks like it was between 2020 and 2024. Okay, so, I mean, it took four years, but, man, that's still a lot. I mean, 2,000 singleton pregnancies were undergoing external cephalic version. Amazing. So short of it is it was group one, which was IV Fentanyl. There was group two, which was IV remifentanil, followed by epidural if the first attempt failed. And then Group 3, of course, were just those undergoing epidural analgesia, and they were trying to see which one worked better. All right, so these are the different time frames. Actually, the 2020 to 2024, that was group three, but group one started 2012 to 2015. So there you go. I mean, you talk about dedication, man. I mean, I guess people hang around here for a while because they started recruiting in 2012. Let me give you these ears, because I see it now in the draft, group one was 2012 to 2015. That was IV remifentanil. That was three years. Then they went 2016 to 2019. That's another three year chunk. That was group two, which was the stepwise right if IV Remy failed and went to epidural. And then the final group was from 2020 to 2024, which was the epidural cohort. Remember, three consecutive phase cohort study. That's how they got close to 2,000 singleton pregnancies in each of the three groups. Amazing. Y' all. Did y' all get this from 2012 to 2024. That is 12 years. Y' all added some dedication. It's like, hey, buddy, how's your. How's your research going? Eight more years to go, Bob. I mean, can you imagine? Hey, how's it going now? Six more years to go, and then two more years. My goodness, the Spanish are just built differently. I mean, kudos to this. This team. Three consecutive phase cohorts from 2012 ending in 2024. Mamma Mia. Wow. I guess drinking some red wine gives you a lot of patience. I don't know. All right, let's get back to this. All procedures followed a standardized protocol. They all were done by experienced obstetricians or supervised by them. In other words, maybe they had the learner. But an attending who knew what they were doing, they all had an anesthesiologist assigned to the patient. Ridadrine was used for topolysis. Notice. That's how you know it's outside of the US because we use terbutaline. And here's the catch. If Ridadrine was not available, they used Atosaban. That's how you know it's not the US because we don't have Atosaban. Atosaban is a uterine muscle relaxer, which is a oxytocin blocker. Okay? We don't have that. So that's how you know what. If you're just reading this and don't pay attention to where it's from, you're like, what? Atosa band. We had that here. No, that's why this was outside of the U.S. short of it is they had those three consecutive buckets, and they want to see very quickly which one worked better. Let's just stop beating around the bush. Epidural wins, epidural wins. Success rates were highest with the epidural at about 70% compared with IV remifentanil or the stepwise progressive approach. Now, here's the catch. If there's a higher chance of version at 70% with the epidural group, then that was also reflected, you would think, in the vaginal delivery rate. And that's exactly what they found. Maternal pain was also much better controlled with the epidural, with 78% of women reporting no or minimal pain, Whereas it was 49% in the REMI group. Okay, so once again, the epidural seems to do its job both for pain control and for success of the version. However. However, the epidural did have more episodes of maternal hypotension with associated dizziness. However, quote, neither was associated with significant obstetric clinical consequences, end quote. So you got to tell the patient, look, we get an epidural, we got the best chance for pain control, best chance to flip that kid, best chance also to relax your muscles, your abdominal muscles. But, you know, we risk a little bit of maternal hypertension. However, based on the studies, the chance that it actually, you know, causes a big issue that makes you get a stat C section is very small. Now, stat C sections are done after a version, but that's usually because prolonged vagal episodes on the child because of manipulation and. Or abruption, which can happen, but thankfully, that's very, very rare. Okay, so in this Spanish study that took 12 years to do, y', all, 12 years to do epidural was their best way to go. So they concluded, and it's also an agreement with acog. Quote in this large cohort, epidural anesthesia for external cephalic version achieved higher success, higher rates of vaginal delivery and better pain control than intravenous remifentanil.
