Exparel users - question for you.

[epidural man]

You are planning on sending the patient home with a sciatic catheter.

However, you want saphenous coverage as well.

Would you feel comfortable doing an adductor canal block with Exparel AND send with a catheter?

The dosage of Exparel is about 1/3 the mg if you sent him home with both front and back catheters (which I have done several times) - so total dosage is way more with two catheters then with what I am proposing.

---

Members don't see this ad.

 

[BLADEMDA]

You are planning on sending the patient home with a sciatic catheter.

However, you want saphenous coverage as well.

Would you feel comfortable doing an adductor canal block with Exparel AND send with a catheter?

The dosage of Exparel is about 1/3 the mg if you sent him home with both front and back catheters (which I have done several times) - so total dosage is way more with two catheters then with what I am proposing.

Yes. I've personally performed hundreds of adductor canal blocks with Exparel. I typically inject 133 mg of Exparel when I know more local anesthetic will be given by the surgeon.
The typical duration of analgesia from 133 mg of Exparel is about 48 hours.

So, in your situation I would perform a single shot adductor canal block utilizing about 133 mg of exparel along with a sciatic catheter and ON-Q type pump.

 

[Scotty_G]

I would like to do what you are doing blade, and I am pretty sure I could convince the surgeons. But...it's my fellow group/anesthesiologists that I'm not sure would go for it. (medico-legal)

 

[BLADEMDA]

I would like to do what you are doing blade, and I am pretty sure I could convince the surgeons. But...it's my fellow group/anesthesiologists that I'm not sure would go for it. (medico-legal)

It's a safe block with minimal motor involvement. The Ortho Surgeons are pleased with the duration of analgesia from 133 mg of Exparel. I utilize Exparel for sensory blocks and field blocks until Pacira gets FDA approval for nerve blocks with motor involvement.

 

[Orin]

I utilize Exparel for sensory blocks and field blocks until Pacira gets FDA approval for nerve blocks with motor involvement.

Is there something special on the labeling for Exparel with sensory blocks? I get the field block part, but I'm unclear as to why you're differentiating the sensory vs motor part. I'd love to use it for "sensory blocks" that are basically field blocks where I don't truly visualize a nerve...

 

[facted]

Is there something special on the labeling for Exparel with sensory blocks? I get the field block part, but I'm unclear as to why you're differentiating the sensory vs motor part. I'd love to use it for "sensory blocks" that are basically field blocks where I don't truly visualize a nerve...

No. This is totally off label use. Only field block is OKd by FDA at this current time.

 

[Orin]

Only field block is OKd by FDA at this current time.

I think they specifically also carve out TAP blocks in addition.

Honestly though, it's the $ vs normal that's the issue. We do tons of off label stuff in Anesthesia right?
Ropi for post-op pain management outside an epidural or local infiltration
Bupi spinals when the vial isn't specifically labelled for spinal administration
Propofol for peds inductions < 3 or pediatric ICU sedation.

And that's even before we get onto the monitors and device BS.

Regardless, I was just wondering if I missed an update about sensory vs motor shenanigans. My major hurdle is using it outside an "operative" event

 

[BLADEMDA]

I think they specifically also carve out TAP blocks in addition.

Honestly though, it's the $ vs normal that's the issue. We do tons of off label stuff in Anesthesia right?
Ropi for post-op pain management outside an epidural or local infiltration
Bupi spinals when the vial isn't specifically labelled for spinal administration
Propofol for peds inductions < 3 or pediatric ICU sedation.

And that's even before we get onto the monitors and device BS.

Regardless, I was just wondering if I missed an update about sensory vs motor shenanigans. My major hurdle is using it outside an "operative" event

My group is over 800 (and counting) Adductor canal blocks using Exparel without any complications. Once we pass the 1,000 mark I'll post again that Exparel is perfectly safe when utilized off-label for certain sensory blocks like Adductor Canal, Paravertebral, Erector Spinae, etc.

There is no scientific basis whatsoever for not utilizing Exparel for these types of blocks. We do off-label drug utilization on a routine basis in Anesthesiology. I'm not stating that one MUST use Exparel but rather you can use it for certain blocks with a lot of confidence concerning its safety.

Adductor Canal Block With Bupivacaine Liposome Versus Ropivacaine Pain Ball for Pain Control in Total Knee Arthroplasty: A Retrospective Cohort Study. - PubMed - NCBI

Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty | Anesthesiology | ASA Publications

 

[facted]

There is no scientific basis whatsoever for not utilizing Exparel for these types of blocks.

No basis except that 30ml of 0.5% bupi and a little decadron provides almost as long a block for a fraction of the cost.

Oh, and that there are no prospective studies looking at either efficacy or safety for nerve blocks. But other than that... No scientific reason whatsoever.

 

[BLADEMDA]

The ACB is an easy and fast peripheral nerve block that can be used to decrease post-operative pain after any procedure involving the anterior knee. The block has been found to be non-inferior to the traditional FNB in terms of analgesia, and has the benefit of limiting or eliminating quadriceps weakness caused by the peripheral nerve block. It also has a low risk for complications. Motor preservation with adequate analgesia has become the optimal postoperative pain goal in orthopedic surgeries. The ACB, as part of a multi-modal pain regimen including opioids, acetaminophen, NSAIDs, possibly gabapentinoids, and LIA, may be the answer.

 

[BLADEMDA]

No basis except that 30ml of 0.5% bupi and a little decadron provides almost as long a block for a fraction of the cost.

Oh, and that there are no prospective studies looking at either efficacy or safety for nerve blocks. But other than that... No scientific reason whatsoever.

How would you know? Since we have performed over 800 of these ACBs with Exparel and another 1,000+ utilizing 0.5% Bup with dexamethasone the data at our institution shows Exparel to be more consistent for analgesia between 24 and 36 hours postop and only Exparel lasts for 48+ hours from a single injection.
So, while the cost for those extras hours of analgesia may not be worth it to you our anecdotal data seems to show that the cost difference is indeed worth it.

If it was my knee I'd prefer the Liposomal based Bupivacaine injection for the ACB. I will however state that there are patients where the Bup plus dexamethasone lasted as long as the Exparel for postop analgesia but the trend for consistency of duration of analgesia was superior with the Exparel.

 

[facted]

How would you know? Since we have performed over 800 of these ACBs with Exparel and another 1,000+ utilizing 0.5% Bup with dexamethasone the data at our institution shows Exparel to be more consistent for analgesia between 24 and 36 hours postop and only Exparel lasts for 48+ hours from a single injection.
So, while the cost for those extras hours of analgesia may not be worth it to you our anecdotal data seems to show that the cost difference is indeed worth it.

If it was my knee I'd prefer the Liposomal based Bupivacaine injection for the ACB. I will however state that there are patients where the Bup plus dexamethasone lasted as long as the Exparel for postop analgesia but the trend for consistency of duration of analgesia was superior with the Exparel.

Like I've said 100 times. When you show me a prospective study comparing the two, I'd consider the cost benefit. Until then, I'll wait.

When the study is done, I'd be shocked if the two were more than 6-8 hrs apart.

 

[BLADEMDA]

Liposomal bupivacaine is a prolonged‐release local anaesthetic, the neurotoxicity of which has not yet been determined. We used quantitative histomorphometric and immunohistochemical analyses to evaluate the neurotoxic effect of liposomal bupivacaine after perineural and intraneural (extrafascicular) injection of the sciatic nerve in pigs. In this double‐blind prospective randomised trial, 4 ml liposomal bupivacaine 1.3% was injected either perineurally (n = 5) or intraneurally extrafascicularly (n = 5). Intraneural–extrafascicular injection of saline (n = 5) was used as a control. After emergence from anaesthesia, neurological examinations were conducted over two weeks. After harvesting the sciatic nerves, no changes in nerve fibre density or myelin width indicative of nerve injury were observed in any of the groups. Intraneural injections resulted in longer sensory blockade than perineural (p < 0.003) without persistent motor or sensory deficit. Sciatic nerve block with liposomal bupivacaine in pigs did not result in histological evidence of nerve injury.


Neurotoxicity of perineural vs intraneural–extrafascicular injection of liposomal bupivacaine in the porcine model of sciatic nerve block


More Evidence of the safety of Exparel
Our study found no histological evidence of neurotoxicity following sciatic nerve block with liposomal bupivacaine.

 

[BLADEMDA]

So, a $50,000 operation and you are squabbling about the $300 local anesthetic for the block? The ACB is key to postop pain control in these patients so even 6-8 additional hours is worth it when the operation costs $50,000.


www.kneereplacementcost.com
The average hospital charge for a total knee replacement (TKR) in the United States is $49,500.

 

[BLADEMDA]

 

[BLADEMDA]

I'll readily admit the Exparel is much, much more expensive than the generic Bupivacaine plus dexamethasone. But, if the operation costs a ton of money like a total knee replacement why not add the $300 local into the mix? No catheters and no pain balls to deal with preop or postop.

 

[BLADEMDA]

 

[BLADEMDA]

One last point about Exparel: If you dilute the drug significantly (concentration less than 0.44%) the duration is significantly decreased to the point it doesn't last any longer than Bupivacaine plus Dexamethasone.

 

[facted]

So, a $50,000 operation and you are squabbling about the $300 local anesthetic for the block

So let's do something that has little evidence behind it and is a lot more expensive because everything else in medicine is expensive??? That's a great attitude. Pacira has taken you to one too many steak dinners.

 

[Hoya11]

You are planning on sending the patient home with a sciatic catheter.

However, you want saphenous coverage as well.

Would you feel comfortable doing an adductor canal block with Exparel AND send with a catheter?

The dosage of Exparel is about 1/3 the mg if you sent him home with both front and back catheters (which I have done several times) - so total dosage is way more with two catheters then with what I am proposing.

I wonder what crazy surgery requires such a plan..

No I would not have a catheter infusing local anesthetic in a different location while the exparel is releasing and doing its thing.

I would worry about LAST from the combination of both sources.
I would rather do 2 catheters and control the rate myself to ensure way under LAST threshold.

But again I wonder why you couldnt just do femoral/acb and a popliteal single shot blocks with bupi and decadron, then po pain medications at home..

 

[BLADEMDA]

It's amazing how many new grads think Dexamethasone is perfectly safe but Exparel is "dangerous." That's simply a false statement and doesn't line up with the facts.
Neither Exparel nor Dexamethasone as an adjuvant are approved by the FDA for peripheral nerve blocks. The published evidence seems to suggest that Dexamethasone at doses greater than 66 ug/ml may be neurotoxic while Exparel displays no neurotoxicity whatsoever using the same rat models. Of course, there are more clinical studies published using Bupivacaine with Dexamethasone for PNBs than there are with Exparel but neither are FDA approved. Both would be off-label uses of FDA approved drugs.

Based on peer reviewed studies and anecdotal data Bupivacaine with Dexamethasone is potentially neurotoxic at commonly used clinical doses by many on SDN. This is in contrast to Exparel where no neurotoxicity has been demonstrated using sciatic nerve tissues from rats.

Neurotoxicity of Adjuvants used in Perineural Anesthesia and Analgesia in Comparison with Ropivacaine

 

[BLADEMDA]

So let's do something that has little evidence behind it and is a lot more expensive because everything else in medicine is expensive??? That's a great attitude. Pacira has taken you to one too many steak dinners.

I've stated the evidence from my institution. You simply choose to ignore it while providing no evidence of your own whatsoever. I'll bet you haven't even used Exparel more than once or twice, if ever, yet you continue to trash it without any clinical basis whatsoever.

 

[BLADEMDA]

 

[BLADEMDA]

Okay, so I'll prove to you that an Exparel block with 133 mg of local combined with another block utilizing Ropivacaine plus a catheter is perfectly safe:

Modeling the Anesthetic Effect of Ropivacaine after a Femoral Nerve Block in Orthopedic Patients:A Population Pharmacokinetic–Pharmacodynamic Analysis | Anesthesiology | ASA Publications

 

[BLADEMDA]

 

[BLADEMDA]

The plasma levels of local anesthetics like Bupivacaine and Ropivacaine can reach 2,000 ng/ml before being even remotely "toxic" levels. So, if one use Exparel 133 mg followed by a bolus dose of local then an infusion the plasma levels never reach toxic levels.
https://oup.silverchair-cdn.com/oup...Do9D4ySa9Q__&Key-Pair-Id=APKAIUCZBIA4LVPAVW3Q

If you wish to respond to this post please use Evidence based medicine like I have posted above. Thanks.

 

[facted]

I've stated the evidence from my institution. You simply choose to ignore it while providing no evidence of your own whatsoever. I'll bet you haven't even used Exparel more than once or twice, if ever, yet you continue to trash it without any clinical basis whatsoever.

You keep touting safety data. That's not what I'm arguing. There's no clinical evidence of efficacy. And no, your anecdotal posts don't count as prospective studies. Sorry.

Just curious: have you ever received an honorium from Pacira, spoken on their behalf, or been to a drug dinner with them?

 

[BLADEMDA]

You keep touting safety data. That's not what I'm arguing. There's no clinical evidence of efficacy. And no, your anecdotal posts don't count as prospective studies. Sorry.

Just curious: have you ever received an honorium from Pacira, spoken on their behalf, or been to a drug dinner with them?

Sure, I've gotten a dinner and two lunches from Pacira. That's it. I don't own their stock and have never received one penny from them in compensation. I'm not the only one on SDN who thinks Exparel is worth the cost in certain situations.

You are beating this to death. You have never used the drug yet continue to bash it. I totally disagree that I have no evidence of efficacy: over 3,000 patients have received Exparel based blocks at my hospital including healthcare professionals, friends and family. All had excellent results in terms of postop pain relief. Exparel works and is at least equivalent to Bupivacaine with Dexamethasone.

 

[Hoya11]

You keep touting safety data. That's not what I'm arguing. There's no clinical evidence of efficacy. And no, your anecdotal posts don't count as prospective studies. Sorry.

Just curious: have you ever received an honorium from Pacira, spoken on their behalf, or been to a drug dinner with them?

"Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL" from the company website.

Then they make a comment that for lidocaine wait 20 minutes.

Why wouldnt they make a comment " Ok for use with catheters?" to clarify, if indeed it were ok.

Why would administering ropivicaine with the catheter not violate the above 96hr recommendation?

Im not going to get out my graphs and calculator here, im just going to follow the manufacturer instructions and not open myself up to liability for minimal benefit should something go awry

 

[BLADEMDA]

"Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL" from the company website.

Then they make a comment that for lidocaine wait 20 minutes.

Why wouldnt they make a comment " Ok for use with catheters?" to clarify, if indeed it were ok.

Why would administering ropivicaine with the catheter not violate the above 96hr recommendation?

Im not going to get out my graphs and calculator here, im just going to follow the manufacturer instructions and not open myself up to liability for minimal benefit should something go awry

Lawyers. The Pacira rep is telling all the surgeons they can inject additional local in the field in addition to mixing the Exparel with Bupivacaine. Exparel is just a drug like any other. The facts are out there. I don't mix Exparel with anything other than normal saline and I use evidence based medicine when performing PNBs at other locations using local anesthetics like Ropivacaine.

But, you should get out your calculator and graphs to prove me wrong and not hide behind the manufacturer's poorly worded instructions. This is the same kind of stuff they all insert in their packages to diffuse liability. Ever read the inserts for LMAs?

 

[facted]

Exparel works and is at least equivalent to Bupivacaine with Dexamethasone.

That's wonderful. You're the one beating this to death. My point, which you still can't refute (you keep posting useless graphs that have nothing to do with this discussion), is that Exparel is BETTER than bupi and dex. There is ZERO evidence that it is. Enough said.

 

[Orin]

Why not both?

http://www.jshoulderelbow.org/article/S1058-2746(16)30455-4/fulltext

Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty

 

[Pooh & Annie]

I won't say it doesn't have benefits over ropi or bupi because I don't know for sure. But I know of several institutions that have used it (both by surgeon in open joints and by anesthesiologists for blocks) and no one has been blown away when comparing it to straight local.

Like I said I'm not saying it won't ultimately be shown to have some durational benefits, but I would guess that if those benefits were truly remarkable we'd have more than a few weak studies and anecdotes supporting it. I bet in most institutions it won't ultimately be considered worth the added cost.

 

[fakin' the funk]

"BLADEMDA," you may have some interesting points to make, but I, for one, can't weed them out from your audacious claims, anecdotes, and spam-posting from, e.g., "kneereplacementcost.com" (you literally googled "knee replacement cost," didn't you?)

*Sigh.*

 

[Southpaw]

"BLADEMDA," you may have some interesting points to make, but I, for one, can't weed them out from your audacious claims, anecdotes, and spam-posting from, e.g., "kneereplacementcost.com" (you literally googled "knee replacement cost," didn't you?)

*Sigh.*

I don't find anything wrong with Blade googling something, and posting it. However, holding so strong to his belief in the superiority of exparel does make him sound like a salesman. I don't get why he's so steadfast in the belief. It's a fine drug. But truthfully it's significantly more expensive than 0.5% Bupi + Decadron, with no real significant clinical difference. At least that is what people who post here see in practice every day. He should at least admit that much.

Full disclosure - all of our orthopedists trialed it, and only one has stuck with it. My group doesn't use the drug at all.

 

[dhb]

Well there is a discrepancy on this board: Exparel expensive bad, Suggamadex expensive good!

I've never tried exparel but if or when we get it i'll definitely try it to make my own opinion.
I've been using dexamethasone in practically all my blocks for 10 years, if i were to wait on the litterature to guide me i would still be doing a lame 16h ropivacaine block.

 

[Southpaw]

Well there is a discrepancy on this board: Exparel expensive bad, Suggamadex expensive good!

I've never tried exparel but if or when we get it i'll definitely try it to make my own opinion.
I've been using dexamethasone in practically all my blocks for 10 years, if i were to wait on the litterature to guide me i would still be doing a lame 16h ropivacaine block.

Sure, try exparel, develop your own opinion. Regarding suggamadex, our hospital says they pay a couple bucks more for sugga than neostigmine + glyco. A dose of exparel is upwards of $300 per my hospital. A dose of 0.5% Bupi + decadron is a few bucks. It's not a fair comparison.

 

[dhb]

Ok forgot about your price for neo, we have it for 4€ vs 80 for Bridion.

 

[BLADEMDA]

I don't find anything wrong with Blade googling something, and posting it. However, holding so strong to his belief in the superiority of exparel does make him sound like a salesman. I don't get why he's so steadfast in the belief. It's a fine drug. But truthfully it's significantly more expensive than 0.5% Bupi + Decadron, with no real significant clinical difference. At least that is what people who post here see in practice every day. He should at least admit that much.

Full disclosure - all of our orthopedists trialed it, and only one has stuck with it. My group doesn't use the drug at all.

As I have posted once you dilute the Exparel with more than 40 mls of saline (total volume of 60 mls or 0.44%) the duration of analgesia decreases to about 20-24 hours which is typically the same as our traditional local anesthetics.

Second, I agree that many patients only get about a 12 hour increase in analgesia vs 0.5% Bupivacaine with Dexamethasone; but, dexamethasone is potentially neurotoxic at many doses used clinically. If you decrease the dexamethasone dosage to the recommended 66 ug per ml of local the advantage shifts heavily to Exparel. The difference becomes readily apparent at that point.

I'm stead-fast in my belief that Exparel is a good drug because of its enhanced safety over 0.5% Bup with dexamethasone with equal to better efficacy provided the concentration remains at least 0.44%.

 

[facted]

As I have posted once you dilute the Exparel with more than 40 mls of saline (total volume of 60 mls or 0.44%) the duration of analgesia decreases to about 20-24 hours which is typically the same as our traditional local anesthetics.

Second, I agree that many patients only get about a 12 hour increase in analgesia vs 0.5% Bupivacaine with Dexamethasone; but, dexamethasone is potentially neurotoxic at many doses used clinically. If you decrease the dexamethasone dosage to the recommended 66 ug per ml of local the advantage shifts heavily to Exparel. The difference becomes readily apparent at that point.

I'm stead-fast in my belief that Exparel is a good drug because of its enhanced safety over 0.5% Bup with dexamethasone with equal to better efficacy provided the concentration remains at least 0.44%.

Given that there is no clinical evidence of dexamethasone leading to neuropraxia, at any dose, this statement is your opinion only. There are many studies looking at perineural dexamethasone, none of which report increase risk of nerve injury.

 

[epidural man]

I wonder what crazy surgery requires such a plan..

No I would not have a catheter infusing local anesthetic in a different location while the exparel is releasing and doing its thing.

I would worry about LAST from the combination of both sources.
I would rather do 2 catheters and control the rate myself to ensure way under LAST threshold.

But again I wonder why you couldnt just do femoral/acb and a popliteal single shot blocks with bupi and decadron, then po pain medications at home..

I guess one may consider toxicity, but our institution recently published a case report where we ran an epidural after an injection of Exparel and measured levels. It is a good discussion about this topic. We also published a poster a year before where we did the same thing (but didn't draw serum levels that time).

Thoracic epidural catheter for postoperative pain control following an ineffective transversus abdominis plane block using liposome bupivacaine

And no - not crazy surgeries. LE surgery often requires coverage of both the femoral branches and sciatic branches.

 

[nimbus]

I guess one may consider toxicity, but our institution recently published a case report where we ran an epidural after an injection of Exparel and measured levels. It is a good discussion about this topic. We also published a poster a year before where we did the same thing (but didn't draw serum levels that time).

Thoracic epidural catheter for postoperative pain control following an ineffective transversus abdominis plane block using liposome bupivacaine

And no - not crazy surgeries. LE surgery often requires coverage of both the femoral branches and sciatic branches.

That is awesome! Answering an important question.

 

[epidural man]

Okay, so I want to discuss a few things.

1. Those who hide behind the FDA as a reason not to use Exparel on a nerve are being grade A hypocrites because they use off-label use of other drugs all the time. IN fact, BLADE - why won't you use Exparel on a peripheral nerve like sciatic?

Here is what we know about depofoam. It was FDA APPROVED for intrathecal use when morphine was used. These are unprotected nerves that are VERY susceptible to injury - yet the FDA had no problem letting this stuff be place intrathecally. We also know bupivicaine is safe in the intrathecal space. We also know there are lots of reports of Exparel placed on nerves with no data to support any danger.

We also know that Amarin succesfully sued the FDA saying they should be allowed to market OFF-LABEL to doctors as long as they told the truth. Why is this important? Because it means the FDA has no jurisdiction to say how a doctor uses a medication. It has ZERO say - and the court case proves it emphatically and clearly.

2. Those that claim that they won't use Exparel on a nerve until a high quality study is done is saying they refuse to use there brain and refuse to use deductive reasoning, and refuse to use available science - and basically are admitting to NOT be a scientist. This is truly sad. Let me explain further. There is NOT convincing evidence that Exparel does NOT work better than straight bupivicaine. I also agree there isn't convincing evidence that the converse is true. So in the absence of this evidence, we need to seek answers. We need to ask questions. And I have question for those that refuse to use it because they think it isn't superior to plain bupi - Why do you think that is? Why doesn't liposomal bupivicaine not work better than straight bupiviciane? Is it because the liposomes don't actually work and all the bupi is released in 24 hours? Is it because the concentration is so low it is ineffective at the sight? Is it because over 3 days, the solution spreads such that it dilutes as it mixes with serous fluid and eventually becomes too low of a concentration?

These are important questions. Is it possible that it matters where the drug is placed? Is it possible that it works well on the sciatic but not the femoral? Does it work better in fascial planes? Does it need a nerve contained in a tight sheet as to keep the drug in the same area?

Rather than say it doesn't work - perhaps we need to ask better questions and figure this out.

I will tell you two things. Liposomal bupiviciane absolutely works over at least 3 days. It may not be clinically useful over 3 days depending on where you put it - but it absolutely elutes over 4 -5 days. This has been shown very clearly with serum level studies.

Second, it absolutely can numb a nerve for 4-5 days. I have used them on peripheral nerves (median, ulnar, sciatic or selectively tibial or common perineal, etc) and I have had patients say their hand was numb for 5 days. I used it for trigger points in the rhomboids, and the patient said their face was numb for 3 days (I guess the stuff spreads when placed in a fascial plane). I have seen great clinical benefit when placed right between the tibial/CP split (so it is contained in the sheath).

To say it doesn't work - is to deny information that is available.

I understand the cost issue. I also understand that it may not work - but certainly more info is needed.

It clearly isn't dangerous - and likely much safer than a catheter of bupivicaine.

And for all those getting on BLADE like he has some disclosures to expose - that is ridiculous. First of all, Pacira is a very small company. If anything, we need to ask you - are you on the pay roll of On-Q? Did Stryker pay you to come on here and bash Exparel? Have you received payment from Purdue pharma?

You really don't think those huge companies with deep pockets and strong lobby power - didn't have anything to do with the struggles Exparel has had with the FDA? They all stand to loose a TON of money if Exparel succeeds. 70% of the FDA money comes from PDUFA - which means drug companies pull the strings - which means Exparel is screwed because they are up against BIG BIG pharma - and you all sound like you are in their pocket.

 

[epidural man]

Given that there is no clinical evidence of dexamethasone leading to neuropraxia, at any dose, this statement is your opinion only. There are many studies looking at perineural dexamethasone, none of which report increase risk of nerve injury.

It also is only marginally better when placed peripherally vs systemically. Why even temp that fate?

 

[facted]

I thought the same thing about peripheral Dex, but more and more studies recently are showing that perineural really does last substantially longer.

When studies come out showing vast superiority for exparel vs bupi/dex in PNB, I'll join the bandwagon.

Until then, I'll leave it you guys. Medicine is riddled with examples of things that made clinical sense and had anecdotal proof that burned up in flames in real trials. I can wait.

And in full disclosure, I haven't even ever been to a drug dinner.

 

[BLADEMDA]

Given that there is no clinical evidence of dexamethasone leading to neuropraxia, at any dose, this statement is your opinion only. There are many studies looking at perineural dexamethasone, none of which report increase risk of nerve injury.

Let's review WHY I choose Exparel for some of my blocks:

1. Safety

2. Efficacy

3. Cost


I readily admit number 3 is very clear: $5 for Bup plus dexamethasone vs $300 for Exparel. It isn't even close here. But, what about items 1 and 2? Why would I choose a very expensive drug over a cheaper one unless there was evidence for it?

 

[BLADEMDA]

Let's focus on item number 1. That's the biggest one for me in terms of my practice. Over the past few years there have been instances of Bupivacaine with dexamethasone causing very prolonged blocks in patients (72 hours or longer) and a few cases of nerve injury. I have had 3 such cases myself and all involved the use of dexamethasone greater than 133 ug/ml. Blockjocks has had at least one case themselves. UNC-Chapel Hill has reported at least one case. These sporadic cases show that dexamethasone used above 133 ug/ml may be neurotoxic as the in-vitro data with rat sciatic nerve tissue demonstrates. I firmly believe that this neurotoxicity is a real concern and dexamethasone should be limited to no more than 100 ug/ml for clinical use. Again, the neurotoxicity of dexamethasone is a real concern and safety issue IMHO.

Hence, I utilize no more than 1 mg of dexamethasone per 10 mls of local anesthetic. That's the maximum I use clinically if I use any at all. While you may not have personally had issues with high dose dexamethasone (greater than 133 ug/ml) there have been many reported instances of nerve injury across the USA.

Exparel has a better safety profile than Bup plus dexamethasone using the same in-vitro data with sciatic rat tissue. This rat data shows dexamethasone greater than 133 ug/ml vs Exparel favors the safety profile of the Exparel.

_______

Now, let's move to item number 2. Since I limit my dexamethasone dose to no more than 1 mg per 10 mls of local, sometimes even 0.5 mg per 10 mls, this decreases the duration of postop analgesia vs the traditional based dosage of at least 200 ug/ml. IMHO, duration of analgesia is reduced to 22-26 hours of postop analgesia for brachial plexus blocks when utilizing low dose dexamethasone. In addition, TAP blocks and adductor canal blocks are typically 24 hours for duration of postop analgesia.

This is in contrast to Exparel which releases Bupivacaine consistently over 40 hours provided the concentration of the drug is more than 0.44%. So, blocks utilizing 0.66% of Exparel appear to provide analgesia in the 40-48 hour range on a much more consistent basis than ones utilizing Bupivacaine plus low dose dexamethasone.

 

[BLADEMDA]

Summary:

1. Safety- Clear winner is the Exparel

2. Efficacy- If low dose dexamethasone is utilized due to item number 1 then the winner is Exparel

3. Cost- Clear winner is the low cost Bup plus dexamethasone

Based on these 3 factors the overall winner is Exparel unless item number 3 is given higher priority over items 1 and 2 combined.

 

[BLADEMDA]

Mackinnon et al. [16] experimented with different steroids in an animal study and reported as followed:

• - Hydrocortisone and triamcinolone caused widespread axonal and myelin degeneration.
  
  
• - Methylprednisolone was moderately toxic.
  
  
• - Dexamethasone was the least neurotoxic agent.
  
  
• - All steroids are neurotoxic when injected in the intrafascicular plane. Injecting in the extrafascicular plane has no effect on the nerve.

Peripheral nerve injection injury with steroid agents. - PubMed - NCBI

 

[BLADEMDA]

Let's focus on item number 1. That's the biggest one for me in terms of my practice. Over the past few years there have been instances of Bupivacaine with dexamethasone causing very prolonged blocks in patients (72 hours or longer) and a few cases of nerve injury. I have had 3 such cases myself and all involved the use of dexamethasone greater than 133 ug/ml. Blockjocks has had at least one case themselves. UNC-Chapel Hill has reported at least one case. These sporadic cases show that dexamethasone used above 133 ug/ml may be neurotoxic as the in-vitro data with rat sciatic nerve tissue demonstrates. I firmly believe that this neurotoxicity is a real concern and dexamethasone should be limited to no more than 100 ug/ml for clinical use. Again, the neurotoxicity of dexamethasone is a real concern and safety issue IMHO.

Hence, I utilize no more than 1 mg of dexamethasone per 10 mls of local anesthetic. That's the maximum I use clinically if I use any at all. While you may not have personally had issues with high dose dexamethasone (greater than 133 ug/ml) there have been many reported instances of nerve injury across the USA.

Exparel has a better safety profile than Bup plus dexamethasone using the same in-vitro data with sciatic rat tissue. This rat data shows dexamethasone greater than 133 ug/ml vs Exparel favors the safety profile of the Exparel.

_______

Now, let's move to item number 2. Since I limit my dexamethasone dose to no more than 1 mg per 10 mls of local, sometimes even 0.5 mg per 10 mls, this decreases the duration of postop analgesia vs the traditional based dosage of at least 200 ug/ml. IMHO, duration of analgesia is reduced to 22-26 hours of postop analgesia for brachial plexus blocks when utilizing low dose dexamethasone. In addition, TAP blocks and adductor canal blocks are typically 24 hours for duration of postop analgesia.

This is in contrast to Exparel which releases Bupivacaine consistently over 40 hours provided the concentration of the drug is more than 0.44%. So, blocks utilizing 0.66% of Exparel appear to provide analgesia in the 40-48 hour range on a much more consistent basis than ones utilizing Bupivacaine plus low dose dexamethasone.

The doses of dexamethasone utilized in clinical practice today probably pose no hazards to the patients provided all the local plus steriod is injected around the nerve. But, if any of the local plus the steroid penetrates the nerve then all bets are off as to the potential nerve damage (neuropraxia) to the patient. In a high volume practice there is always the small chance of 1-2 mls being injected in the wrong location so that is the reason for the concern and the debate over the safety profile of perineural dexamethasone.

So, whether or not you continue to utilize high dose dexamethasone in your practice is your decision; but, the concern over the safety of perineural dexamethasone and what, if any, is the safe dose for the adjuvant drug remains an issue.