I think you are confused. There are plenty of non-Pacira-funded/controlled RCTs showing no difference between Exparel and plain bupi.
What blocks are you using exparel for?
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Which studies are you referring to? If you read the meta analysis that lead to the lawsuit, they included 9 studies. 4 of those were taken from clinicaltrials.gov and never actually published. And of the rest, only one was interscalene blocks (Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery - PubMed), the rest were intercostal, fascia iliaca or dorsal penile block.
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Residents if you have them. Education from ortho office visit and ortho nurses. Reiterate education Pre-op and pacu. Residents call each afternoon and on 3rd day . Patient pull cath at home while on the phone. We had very few/no serious problems. Getting pulled out or coming unattached most common.
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The patients pull the catheters. We have a robust system where they call the pump mfr or the surgery dept before calling the anesthesia dept or on call anesthesiologist directly. (The most common question is "can I take my Percocet" YES OF COURSE) Thorough standardized discharge instructions and a post-op day 1 phone call. Occasionally a patient comes to the ED for a disconnected or dislodged catheter, which is a headache, but vast majority of the time these are smooth sailing.
I counsel patients that a catheter is more reliable and titratable, but more work; an Exparel block is not reliable, likely to be shorter, but zero work. Some folks lean strongly one way or another and some folks I "make" the decision for.
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Liposomal Bupivacaine for Peripheral Nerve Blockade: A... : Anesthesiology
istics, the authors designed a randomized, controlled, triple-blinded, single-center study in volunteers. Methods Volunteers aged 18 to 55 yr (body mass index, 18 to 35 kg/m2) received two ulnar nerve blocks under ultrasound guidance. Using a crossover design with a washout phase of 36 days or...
pubs.asahq.org
Exparel slower onset, less complete block, and shorter duration??
I dislike liposomal bupivacaine, but Anesthesiology clearly cherrypicked a crappy study to show what they wanted to show. Ulnar blocks with 3cc volumes on healthy volunteers? The Exparel group received 1cc of liposomal bupivacaine + 2cc of NS while the plain bupi group got a full 3cc of bupi? Even the mg of bupi weren't even between the two groups. This is applicable to nothing. Joke of an article.Liposomal Bupivacaine for Peripheral Nerve Blockade: A... : Anesthesiology
istics, the authors designed a randomized, controlled, triple-blinded, single-center study in volunteers. Methods Volunteers aged 18 to 55 yr (body mass index, 18 to 35 kg/m2) received two ulnar nerve blocks under ultrasound guidance. Using a crossover design with a washout phase of 36 days or...
Exparel slower onset, less complete block, and shorter duration??
That being said, liposomal bupivacaine results in crappier blocks than plain bupivacaine and it's not hard to see that clinically. However, their crappier block prolly lasts a little longer but who cares (it is still crappier block). This study is absolute trash though. I expect nothing less from Anesthesiology. They publish less than one good/relevant article per year nowadays.
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But nobody (except maybe some surgeons that don't know any better) uses exparel by itself.Liposomal Bupivacaine for Peripheral Nerve Blockade: A... : Anesthesiology
istics, the authors designed a randomized, controlled, triple-blinded, single-center study in volunteers. Methods Volunteers aged 18 to 55 yr (body mass index, 18 to 35 kg/m2) received two ulnar nerve blocks under ultrasound guidance. Using a crossover design with a washout phase of 36 days or...
Exparel slower onset, less complete block, and shorter duration??
What a wasted opportunity. Why not just do exparel w/bupi vs bupi head to head. Serious waste of money.
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There is no doubt in my mind that liposomal bupi results in ****ty blocks. The way the drug works makes it have less diffusion compared to plain bupi and as a result will amplify less than optimal local placement. You can get away with poor local deposition by using high volumes of regular bupi because enough of it will make its way into the nerve bundle.
Why? Because there is an increased likelihood of a negative study at their small n of 25 volunteers in each group. Anesthesiology would never accept (or even review) a study showing similar sensory blockade/duration between liposomal bupi/bupi mix versus plain bupi. They would only want a study showing that liposomal bupi/bupi mix is inferior. Too risky at that n.
If anyone is doing a clinically relevant prospective, randomized regional anesthesia study, it definitely isn't being published in Anesthesiology (or RAPM, for that matter). Both strive to only publish irrelevant, controversial stuff that will bump up their impact factor.
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I have been using Exparel for over a decade. This study was simply garbage. Exparel has its limitations but I still like it for some situations.
For field blocks like TAP, QL, ESP, etc I think Exparel mixed with Bupivacaine gives pretty good analgesia for 24-36 hours. Sure, some of you may say that Bup with Decadron does the same thing but in my experience, I still prefer the Exparel/Bup mixture. I have NOT found the Exparel/Bup mixture superior for brachial plexus blocks vs Bup plus Dexamethsaone because there is too much variability in the duration of analgesia in the former vs the later. When you factor in the cost then Bup + Dex is even a better deal clinically.
Finally, for Popliteal blocks when all you need is mild analgesia, I think exparel/Bup mixture is both safer and longer duration than Bup + dexamethasone.
I was always curious about a Femoral block for outpatient total knee replacement. A mixture of 0.125% Bup with 133 mg or 266 mg of Exparel may be the ticket for outpatient total knees. The patient could ambulate post op, get 24 hours + of analgesia, then head home. In our legal climate, this would take several clinical studies to validate the safety of such an approach, but I think it holds a lot of promise vs our standard Adductor canal block. This is a situation that the very weak motor block from Exparel would be an advantage over Bupivacaine and Ropivacaine while still providing 24 hours of analgesia.
For field blocks like TAP, QL, ESP, etc I think Exparel mixed with Bupivacaine gives pretty good analgesia for 24-36 hours. Sure, some of you may say that Bup with Decadron does the same thing but in my experience, I still prefer the Exparel/Bup mixture. I have NOT found the Exparel/Bup mixture superior for brachial plexus blocks vs Bup plus Dexamethsaone because there is too much variability in the duration of analgesia in the former vs the later. When you factor in the cost then Bup + Dex is even a better deal clinically.
Finally, for Popliteal blocks when all you need is mild analgesia, I think exparel/Bup mixture is both safer and longer duration than Bup + dexamethasone.
I was always curious about a Femoral block for outpatient total knee replacement. A mixture of 0.125% Bup with 133 mg or 266 mg of Exparel may be the ticket for outpatient total knees. The patient could ambulate post op, get 24 hours + of analgesia, then head home. In our legal climate, this would take several clinical studies to validate the safety of such an approach, but I think it holds a lot of promise vs our standard Adductor canal block. This is a situation that the very weak motor block from Exparel would be an advantage over Bupivacaine and Ropivacaine while still providing 24 hours of analgesia.
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Results from the primary and secondary efficacy analyses showed that liposome bupivacaine 266 mg in a femoral nerve block was associated with a modest but statistically significant reduction in cumulative pain intensity scores and opioid consumption through 72 h postsurgery compared with placebo. Results from the per-protocol tertiary analyses, which included imputed pain scores, showed that AUC of NRS scores for pain at rest were lower in the liposome bupivacaine group during all three of the 24-h intervals (0 to 24, 24 to 48, and 48 to 72 h) after surgery. However, a post hoc analysis of cumulative pain scores, which included only unimputed pain scores, showed a significant difference in favor of liposome bupivacaine only during the 0- to 24-h and 24- to 48-h periods after surgery.
Anesthesiology
pubs.asahq.org
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View attachment 388393
Results from the primary and secondary efficacy analyses showed that liposome bupivacaine 266 mg in a femoral nerve block was associated with a modest but statistically significant reduction in cumulative pain intensity scores and opioid consumption through 72 h postsurgery compared with placebo. Results from the per-protocol tertiary analyses, which included imputed pain scores, showed that AUC of NRS scores for pain at rest were lower in the liposome bupivacaine group during all three of the 24-h intervals (0 to 24, 24 to 48, and 48 to 72 h) after surgery. However, a post hoc analysis of cumulative pain scores, which included only unimputed pain scores, showed a significant difference in favor of liposome bupivacaine only during the 0- to 24-h and 24- to 48-h periods after surgery.
Anesthesiology
All that shows is that exparel works modestly better than saline. How many saline blocks do people do? It was so messed up that they used saline in the control arm. In my opinion that is unethical. Control arm patients got some of the risks of a nerve block with no plausible benefit.
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That study is an embarrassment to the journal. 266mg Exparel with a small (no more than 50% plain Bupivicaine) works fantastic for brachial plexus and sciatic blocks. The meaningful endpoints are patient satisfaction and patients are equally satisfied to catheters from a pain standpoint and like the lack of equipment much better.
That would be the only meaningful study I would want to see-head to head over 48 hours and 72 hours
Catheter vs Exparel (266 mg). Post surgical pain. Wish someone would do it.
Not sure on adductor or femorals haven’t done for fear of any prolonged quad weakness….but I can tell you our surgeons would protest outside the hospital if idea of bringing back catheters and taking away Exparel was ever discussed
That would be the only meaningful study I would want to see-head to head over 48 hours and 72 hours
Catheter vs Exparel (266 mg). Post surgical pain. Wish someone would do it.
Not sure on adductor or femorals haven’t done for fear of any prolonged quad weakness….but I can tell you our surgeons would protest outside the hospital if idea of bringing back catheters and taking away Exparel was ever discussed
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They make a point of noting that this was a "study designed to meet the U.S. Food and Drug Administration (FDA) standard for approval of analgesic agents, which rests on comparison of investigational agents versus placebo in well-matched populations" and that Exparel doesn't yet have FDA approval for PNBs. So even though the abstract makes efficacy claims (which are irrelevant because it's vs placebo), the study itself wasn't really done for that reason.
Why would anyone (outside of an FDA submission) reference or quote this article? The senior author would likely redact this article if he could. The company's fingerprints are all over this awful study. This is purely an FDA Phase 3 requirement. They chose to compare it to placebo for a very, very good reason. Exparel wouldn't be FDA approved if the comparator was plain bupivacaine. We all know that.View attachment 388393
Results from the primary and secondary efficacy analyses showed that liposome bupivacaine 266 mg in a femoral nerve block was associated with a modest but statistically significant reduction in cumulative pain intensity scores and opioid consumption through 72 h postsurgery compared with placebo. Results from the per-protocol tertiary analyses, which included imputed pain scores, showed that AUC of NRS scores for pain at rest were lower in the liposome bupivacaine group during all three of the 24-h intervals (0 to 24, 24 to 48, and 48 to 72 h) after surgery. However, a post hoc analysis of cumulative pain scores, which included only unimputed pain scores, showed a significant difference in favor of liposome bupivacaine only during the 0- to 24-h and 24- to 48-h periods after surgery.
Anesthesiology
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I'm as big an Exparel hater as any other sensible person, but this is kind of ridiculous.
By redact do you really mean retract? Either way that doesn't make any sense.
They chose to compare it to placebo because that's what the FDA requires. FDA approval is based on safety and efficacy. To get approved, a drug doesn't necessarily need to be better than other available options. It just needs to be safe and have a positive measurable effect. Exparel appears to check those boxes.
Just because the FDA will likely approve it for PNBs doesn't mean you have to use it. I won't.
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As I mentioned earlier in this thread, I'm not convinced ultra long block duration is desirable in the first place, even though it's taken as an article of faith by many that longer block = better. Amputations and really severe extremity trauma are about the only cases for which I'd desire an extended duration block.
Maybe if it cost pennies? And gave duration/density superior to bupivacaine + dexamethasone? (I mean perineural dex, not IV dex - that study claiming IV dex = perineural dex was dumb.)
99% of the blocks I do are plain 0.5% ropivacaine. I didn't do a regional fellowship and don't claim to be anything more than generally competent when it comes to regional. I don't do a lot of blocks because I don't do a lot of ortho, but plain ropi seems to work just fine.
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I've used Exparel for interscalene and TAP blocks and consider it suitable for supraclavicular blocks as well. However, I would not use Exparel for the popliteal block due to its higher risk of nerve injury. The popliteal fossa is often compressed when non-weight bearing, and the use of a tourniquet adds further risk.
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I like exparel for tap blocks and interscalene. For totals knees just mepi spinal and bupi 0.5 20 cc + decadron in popliteal, 10-20 for the adductor. They do well and go home same day. For total shoulders bupi 20 cc then exparel 10 cc separate syringes, I don't mix it because I've seen many other people get incomplete blocks. If it works well people get good analgesia for 3-5 days. For taps I do mix it because you're probably going to get an incomplete block anyway and patients seem to do pretty well for at least the first 24 hours.
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They work with pt before they go. Also they get local infiltration by the surgeon
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How much local are they putting in the joint? Also are they using straight bupi?
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We also can trick ourselves into believing adductors actually work when honestly local around the joint is enough.
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Pacira Biosciences stock plummets 48% as judge rules Exparel patent invalid
Pacira Biosciences (PCRX) shares dive after judge rules patent for best-selling drug Exparel is valid, generic maker eVenus plans launch if they win case.
seekingalpha.com
Ouch
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133mg w 10cc of .5% bupi for TSA/RTSA only.
Not a huge benefit, but some.
Not a huge benefit, but some.
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I had a podiatrist ask me if I was going to use Exparel in a popliteal block yesterday.
I just laughed and said no. I'm not even sure where to find it, if it's in a Pyxis somewhere or if I would have to call the pharmacy.
I just laughed and said no. I'm not even sure where to find it, if it's in a Pyxis somewhere or if I would have to call the pharmacy.
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I dont use it. 0.25% Bupi or 0.2% Ropi + 10mg dexamethasone PF or 100mcg clonidine.
Lasts up to 2-3 days on most patients. One had a block for 5 days recently and was getting concerned.
Lasts up to 2-3 days on most patients. One had a block for 5 days recently and was getting concerned.
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Exparel vs plain bupiv 0.5% head to head. Prospective DB RCT from Hong Kong. SCB for distal radius fractures.
pubs.asahq.org
pubs.asahq.org
Anesthesiology
pubs.asahq.org
Anesthesiology
pubs.asahq.org
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Statistically significant 1.1 vs 1.7 pain scores on day 1, with no difference on day 2+.Exparel vs plain bupiv 0.5% head to head. Prospective DB RCT from Hong Kong. SCB for distal radius fractures.
Anesthesiology
Anesthesiology
Clinically insignificant. Ridiculously higher cost. So much for the 72 hour promise.
No thanks.
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You have to use 20ml Exparel and 10cc or less plain bupivicaine. That is yet another study using only 10ml Exparel.
It works very well. Has become the goto at Duke, UNC…etc. again do 100 interscalenes or more popliteals with 20ml Exparel and call patients. If you still don’t believe then ok I’ll listen, but until then everyone needs to quit quoting studies using only 10ml Exparel. It’s meaningless. It 100% lasts 2-4 days. Usually closer to 3….with 20ml Exparel
It works very well. Has become the goto at Duke, UNC…etc. again do 100 interscalenes or more popliteals with 20ml Exparel and call patients. If you still don’t believe then ok I’ll listen, but until then everyone needs to quit quoting studies using only 10ml Exparel. It’s meaningless. It 100% lasts 2-4 days. Usually closer to 3….with 20ml Exparel
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Do the study.
Publish it.
It's a crappy drug pushed by a crappy sleazy company. Its use is "supported" by a bunch of crappy studies.
You think quoting your anecdotal observations is better?
If your technique is so awesome, do the study, publish it. I hear Duke, UNC, etc have passably good research support.
Not at either in private practice so no study coming here. But I can tell you Exparel is drug of choice in NC for good reason and good luck telling any of these surgeons you’re not going to use it anymore for shoulders or ankles. Catheters are gone. Again use 20mls for 100 patients. Call the patients. Once you do that and want to argue the effectiveness by all means
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No thanks
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Study was out of Hong Kong, not North Carolina. Average patients were 60-65kg. How much exparel+plain bupiv would you have used for a SCB? If 133mg in 10 ml is not effective, why do they even make a 10ml vial?
Also why is Pacira promoting 10ml for brachial plexus block if it doesn’t work?
“The recommended dose of EXPAREL in adults for interscalene brachial plexus nerve block and sciatic nerve block in the popliteal fossa is 133 mg (10 mL). The recommended dose of EXPAREL in adults for an adductor canal block is 133 mg (10 mL) admixed with 50 mg (10 mL) 0.5% bupivacaine HCL, for a total volume of 20 mL.”
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So, in PP, you are personally calling every one of your block patients daily through POD4?
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LOL - the very notion of it is ridiculous.
I'm sure their level of evidence is hearing from the ortho-bro something like "what up gas-bro, the NP who I pay to talk to my TKAs postop so I don't have to didn't say anything about pain so it must be good, keep on needling the milky bone-un-hurting juice and good job with the Ancef" ...
Also, since I haven't mentioned it yet in this particular Exparel thread, I'll just go ahead and ask out loud whether or not these multi-day peripheral nerve blocks are even desirable in the first place.
I could come into your place tomorrow and replace all those blocks with 0.5% bupi with dex and no one would know any difference at any time
No kidding study was in Hong Kong. I was just mentioning that both the major academic programs and most of NC now used Exparel for brachial plexus and sciatic.
Yes our PP called when we launched Exparel. Called first 500. Stopped after that as was so successful.
I would have still used 20 ml Exparel plus a little 0.5% bup on patients 60-65kg.
You are correct to point out Pacira only using 10ml. This was a huge flaw by them. The problem was they were so anxious to get approval for nerve blocks in interscalenes they just used 10mls as wanted quickest route to approval. So short sighted on their part. Because Exparel was only initially studied in brachial plexus and approved for 10mls is why you see all these studies using only 10mls. However, Exparel is safe at 20mls and when approved for sciatic they used 20mls I believe.
Hopefully someone out there is doing a study in brachial plexus with 20mls…and no more than 10mls plain bupivacaine. I again assure you it’s effective in the 50-80 hour range.
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Fwiw this is the guidance from Pacira. That said, I don’t doubt that larger volumes yield longer blocks. This is true for plain old bupivacaine too.
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20mls absolutely safe from toxicity standpoint. Comes in 20ml bottles too. Most practices I know use 20mls. 10mls only lasts 35-40 hours. No different than Bupivicaine with adjuvants. The other key is you want to try and be 2:1 and no less than 1:1 Exparel:Bupivicaine. More you dilute it also affects duration.
I use 20ml Exparel with 5ml 0.5% Bupivicaine for brachial plexus. Reliably 60/70 hour of excellent pain control. Block does have a longer set up time as little plain Bupivicaine-why most people use 10ml 0.5% bupivicaine but I just don’t see need for 30mls. For a combine popliteal/saphenous I do use 30ml mixture though
I use 20ml Exparel with 5ml 0.5% Bupivicaine for brachial plexus. Reliably 60/70 hour of excellent pain control. Block does have a longer set up time as little plain Bupivicaine-why most people use 10ml 0.5% bupivicaine but I just don’t see need for 30mls. For a combine popliteal/saphenous I do use 30ml mixture though
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In regional fellowship we followed these patients and they could reliably get up to 4 days of analgesia from an interscalene block with 20ml of exparel. Roughly 40 minutes to onset of motor block
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Hopefully somebody will publish a series demonstrating 70-90hrs of analgesia one day. Based on your reports it should not be hard. Also, how long does the motor block last?
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All these busy PP anesthesiologists reporting personal case series showing amazing results, plus or minus an attaboy from ortho. I wonder why no one has published a study showing superiority over plain bupi or bupi+dex. In this publish or perish dog-eat-dog world, seems like a chip shot to get yourself on the cover of a journal.
Instead all we get are studies like the one linked a few posts back, which touted a statistically significant day one p value between pain scores of 1.1 and 1.7 ... yay?
Again I'll ask - do we really actually even WANT to have multi-day nerve blocks? I know everyone fears opioids now, but are a couple of oxycodone tablets and a functional sensate arm really such a bad thing on POD 2 or 3?
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I agree with you. Day 3,4 nerve blocks makes me feel a bit nervous about total recovery of nerve function. Pgg you remember the sickle cell patients we used to get? Those patients would certainly benefit from multi day nerve blocks. But your shoulder scopes and acls should have normal sensation after day 2.
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The lack of critical thinking around this drug blows my mind. Like no one believes that a for profit study would cherry pick results and then push a high cost ineffective drug on anyone that will listen.
Also, how many patients tell you it lasts for 2-4 days because you bloody told them it would last that long? Have you really never heard of the placebo effect?
I had a PA once tell me, "I know you anesthesiologists don't like this drug, but I've seen it work. It just doesn't do well in studies."
Also, how many patients tell you it lasts for 2-4 days because you bloody told them it would last that long? Have you really never heard of the placebo effect?
I had a PA once tell me, "I know you anesthesiologists don't like this drug, but I've seen it work. It just doesn't do well in studies."
