First Exparel reaction

[sevoflurane]

Dual inguinal/umbilical hernia repair. Tap Block at the end of the case + infiltration around the umbilical hernia site. Patient with very little pain post-op.
Discharged home from secondary.
Rash starts to appear about 24 hours later in the distribution of the TAP block and around the umbilical infiltration site. Placed on antibiotics as a precaution. At 48 hours the patient continues to develop a pruritic, edematous rash.
Clear cut reaction to exparel. Apparently it has been described. This is my first local anesthesia reaction in my entire career.
Giong back to plain .5% Marcaine with epi + decadron for TAP blocks.

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[urge]

Maybe not a great idea.

 

[BuzzPhreed]

Hmmm... I know you placed this block aseptically, but... and...

Mesh? There have also been similar reactions to implanted mesh.

http://www.aaaai.org/ask-the-expert/allergy-to-polypropylene-mesh.aspx

Either way, I would refer the patient for allergy testing. As most everyone on here should know, a true allergy to amide-class local anesthetics is extremely low. The patient should be tested for that and for a reaction to the liposomal vehicle if a true delayed-type allergic reaction is expected. You don't want them getting labeled for life with an allergy to bupivicaine. (That's what a low-performing HODAD or CRNA would do, not a true expert anesthesiologist.)

Also, in my practice, I don't completely refuse to do a subsequent procedure or technique if my adverse reaction profile goes from N=0 to N=1. I think this is an opportunity to figure out what happened, adjust, and if necessary change. It doesn't mean abandon what I've done successfully countless time before, especially if whatever I was doing wasn't inherently risky.

But that's just this one dude's opinion.

 

[BLADEMDA]

280 Tap blocks with Exparel...Zero Complications so far.

 

[Noyac]

280 Tap blocks with Exparel...Zero Complications so far.

Blade, why are you doing so many tap blocks if the epidural is a better block? Do you have this many pts that are not candidates for epidurals?

 

[sevoflurane]

Clear cut reaction to exparel as there was no mesh used at the umbilical site. Furthermore, the reaction is exactly in the area that I injected and traveled down the same pathway as the hydrodissection btw the TA and IO. Reaction around the umbilical site is further proof that is icing on the cake.

I've been doing TAPs for 5 years... even longer if you include the pedi population. This reaction was not a little puritic rash, it was a NASTY reaction I wish upon none of my patients. The reaction is a known side effect. I never said anything about labeling the patient allergic to marcaine (big difference). He is, however, allergic to exparel. IF the patient desires to be tested for an allergy to exparel, then that's his choice... expensive and the outcome will be exactly the same = allergic. I would argue that sending the patient for allergy testing is a complete waste of time, money and resources... that sounds more like a midlevel move to me.

Tried and tested and cost is exactly why I choose to go back to my old cocktail.

Anyways, this post is here to share my experience with a group of intelligent docs who frequently use exparel. I've been using it for a lot longer than many on this board and I just wish I could show you guys the reaction this patient had. Obviously, I can’t do that… but take my word for it… it was a severe reaction I don’t ever want to see again.

I’m done with exparel for now.

 

[BLADEMDA]

Clear cut reaction to exparel as there was no mesh used at the umbilical site. Furthermore, the reaction is exactly in the area that I injected and traveled down the same pathway as the hydrodissection btw the TA and IO. Reaction around the umbilical site is further proof that is icing on the cake.

I've been doing TAPs for 5 years... even longer if you include the pedi population. This reaction was not a little puritic rash, it was a NASTY reaction I wish upon none of my patients. The reaction is a known side effect. I never said anything about labeling the patient allergic to marcaine (big difference). He is, however, allergic to exparel. IF the patient desires to be tested for an allergy to exparel, then that's his choice... expensive and the outcome will be exactly the same = allergic. I would argue that sending the patient for allergy testing is a complete waste of time, money and resources... that sounds more like a midlevel move to me.

Tried and tested and cost is exactly why I choose to go back to my old cocktail.

Anyways, this post is here to share my experience with a group of intelligent docs who frequently use exparel. I've been using it for a lot longer than many on this board and I just wish I could show you guys the reaction this patient had. Obviously, I can’t do that… but take my word for it… it was a severe reaction I don’t ever want to see again.

I’m done with exparel for now.

So you had ONE patient with a reaction to Exparel. Everything we do has risks/benefits. There is no free lunch. The safety profile of Exparel is excellent and if one out of 250,000 or even 1 out of 1 million patients has a reaction we should all abandon the drug? How do you know this patient isn't allergic to regular old Bupivacaine? I do agree that Bup would only last 24 hours while Exparel sticks around for 48+ hours but I'm not ready to stop using a proven, efficacious drug because of an isolated reaction.

I appreciate your posting this thread as it makes us all aware that there are NO FREE LUNCHES even for a 99.9% safe procedure like a TAP with EXPAREL.

 

[BLADEMDA]

Blade, why are you doing so many tap blocks if the epidural is a better block? Do you have this many pts that are not candidates for epidurals?

My patient satisfaction scores utilizing Tap blocks as described by Hebbard with Exparel plus Decadron is close to that of Epidural analgesia without any of the postop issues/hassles. Both Surgeons and Patients are extremely satisfied with the technique.

 

[sevoflurane]

So you had ONE patient with a reaction to Exparel. Everything we do has risks/benefits. There is no free lunch. The safety profile of Exparel is excellent and if one out of 250,000 or even 1 out of 1 million patients has a reaction we should all abandon the drug? How do you know this patient isn't allergic to regular old Bupivacaine? I do agree that Bup would only last 24 hours while Exparel sticks around for 48+ hours but I'm not ready to stop using a proven, efficacious drug because of an isolated reaction.

I appreciate your posting this thread as it makes us all aware that there are NO FREE LUNCHES even for a 99.9% safe procedure like a TAP with EXPAREL.

He's not allergic to regular Bupivicaine because he's had it before. Exparel is expensive. I have years of satisfied patients with my old cocktail. Physician preference.

 

[BLADEMDA]

He's not allergic to regular Bupivicaine because he's had it before. Exparel is expensive. I have years of satisfied patients with my old cocktail. Physician preference.

Fine. I get it. You are now anti-Exparel because of ONE allergic reaction. Has anyone else had a similar case? What's the incidence of this allergy? Is your cocktail truly a MATCH for the Exparel cocktail of Exparel, Decadron, Buprenorphine +/- Clonidine? Is $280 really that much money these days for outstanding postop pain relief when most operations easily exceed $6,000? Have you seen the cost of BIOLOGICAL MESH? Anyway, I hope things work out for you and I will post any NEGATIVE reactions to Exparel as I continue to use it daily in my practice.

 

[BLADEMDA]

On March 14th, Dr. John Barrington presented during a podium session a prospective, case-controlled study comparing 1000 TJAs using EXPAREL-based multimodal therapy to 1000 TJAs using standard pain management regimens. The most significant benefits of EXPAREL were a reduction in the pain score from 2.41 to 1.98 (p<0.0001) and a savings of $1,246.11 per case. “. . . Optimizing post-surgical pain management is of increasing importance to clinicians, hospitals, and payers,” said Dr. Barrington. “Our data found that an EXPAREL-based regimen not only improves pain scores and patient satisfaction, but also moves the needle on length of stay and hospital costs. From my perspective, these outcomes represent a win-win for all key stakeholders in the healthcare system–hospitals looking to keep costs down without compromising care, payers looking to minimize incremental costs associated with complications that delay discharge, and most importantly, patients who want a comfortable recovery.”

Following Dr. Barrington at a poster was Dr. Roger Emerson, Jr., who presented a retrospective analysis of 72 knee replacements comparing pain control and post-surgical opioid use between patients receiving EXPAREL or continuous femoral nerve block. Although these patients had comparable average pain scores (1.8 for EXPAREL and 2.3 for nerve block), EXPAREL patients had no incidence of quadriceps weakness and a significantly lower opioid consumption (p<0.0001). “Based on our data and clinical practice, EXPAREL as part of a multimodal pain management regimen has shown promise in circumventing the downsides of nerve blocks, without compromising superior pain control,” said Dr. Emerson.

http://bionews-tx.com/news/2014/03/...t-benefits-of-exparel-for-pain-following-tja/

 

[BLADEMDA]

Tens of thousands of patients have received Exparel without any adverse reaction to the drug. That said, there is bound to be someone allergic to the LIPOSOMAL FORMULATION or the BUPIVACAINE in Exparel. Sevoflurane found that someone.

Exparel is COST EFFECTIVE in the right patient population. I highly recommend Exparel over any Bupivacaine cocktail especially if the patient has insurance (not governmental payors). Exparel costs the patients ZERO if they are outpatient procedures. For inpatients the hospitals are NOT likely to get reimbursed but the benefits of Exparel make its use cost neutral at worst and cost effective at best.

 

[sevoflurane]

and then there is this:

http://www.ncbi.nlm.nih.gov/pubmed/24793570

After the initial 24h, inpatient self-reported pain scores were higher in the liposomal bupivacaine group compared to the traditional PAI group (P = 0.04) and a smaller percentage (16.9%) of patients in the liposomal bupivacaine group rated their pain as "mild" compared to the traditional group (47.6%). Liposomal bupivacaine PAI provided inferior pain control compared to the less expensive traditional PAI in a multi-modal pain control program in patients undergoing TKA.


Don't turn this into a flame war Blade. I'm simply reporting a severe allergic reaction. This is a new drug and I'm treating it as such. I'm not sure I'm the "one" in a million for the reaction. That is yet to be determined. Take it or leave it.
No need to get angry. Keep it professional.

 

[Planktonmd]

I think Exparel is destined to join other great medications that are struggling to find a real indication like Precedex and Remifentanyl...!
Go ahead... shoot the messanger

 

[BLADEMDA]

and then there is this:

http://www.ncbi.nlm.nih.gov/pubmed/24793570

After the initial 24h, inpatient self-reported pain scores were higher in the liposomal bupivacaine group compared to the traditional PAI group (P = 0.04) and a smaller percentage (16.9%) of patients in the liposomal bupivacaine group rated their pain as "mild" compared to the traditional group (47.6%). Liposomal bupivacaine PAI provided inferior pain control compared to the less expensive traditional PAI in a multi-modal pain control program in patients undergoing TKA.


Don't turn this into a flame war Blade. I'm simply reporting a severe allergic reaction. This is a new drug and I'm treating it as such. I'm not sure I'm the "one" in a million for the reaction. That is yet to be determined. Take it or leave it.
No need to get angry. Keep it professional.

I'm not angry. Think of how many bottles of Exparel have been used by Physicians since its release. How many case reports of severe allergy exist? Or, what about those large trials utilizing Exparel or my hospital where over 1,000 bottles have been used? I'm not aware of a single reaction to the drug except the one you posted. So, this is a 1 in 100,000 type event or even rarer. I'm not dismissing it or saying that it can't happen to one of my patients but rather it is a rare event.

As far as the efficacy of Exparel vs Bupivacaine that is another discussion altogether. Exparel is an awesome drug which can reduce postop pain and reduce hospital costs. Some of you remain unconvinced Exparel is worth $280 per bottle vs $3 for Bupivacaine (or $15 for Ropivacaine) and I don't blame you. Is an extra 24 hours of post op pain relief worth $277 more? I think the answer is yes for the right patient population.

 

[BuzzPhreed]

IF the patient desires to be tested for an allergy to exparel, then that's his choice... expensive and the outcome will be exactly the same = allergic. I would argue that sending the patient for allergy testing is a complete waste of time, money and resources... that sounds more like a midlevel move to me.

No, the midlevel move would be to simply label them allergic to bupivicaine, which was my point. And I'm willing to bet that will be part of the conversation this patient has with their "provider" at every point in the future. How do you know - right now - it wasn't an amide allergy? Rare, but it happens. Willing to bet that without further testing that "local anesthetic" is added to the patient's allergy list?

I've been using it for a lot longer than many on this board...

Which is what is confusing to some of us.

... and I just wish I could show you guys the reaction this patient had. Obviously, I can’t do that… but take my word for it… it was a severe reaction I don’t ever want to see again.

None of us doubts you. I just want you to take it over the goal line now.

I think Exparel is destined to join other great medications that are struggling to find a real indication like Precedex and Remifentanyl...!
Go ahead... shoot the messanger

I've been saying this for a long time. It is not a superior medication. It's a marketing gimmick.

 

[sevoflurane]

I'm not angry. Think of how many bottles of Exparel have been used by Physicians since its release. How many case reports of severe allergy exist? Or, what about those large trials utilizing Exparel or my hospital where over 1,000 bottles have been used? I'm not aware of a single reaction to the drug except the one you posted. So, this is a 1 in 100,000 type event or even rarer. I'm not dismissing it or saying that it can't happen to one of my patients but rather it is a rare event.

As far as the efficacy of Exparel vs Bupivacaine that is another discussion altogether. Exparel is an awesome drug which can reduce postop pain and reduce hospital costs. Some of you remain unconvinced Exparel is worth $280 per bottle vs $3 for Bupivacaine (or $15 for Ropivacaine) and I don't blame you. Is an extra 24 hours of post op pain relief worth $277 more? I think the answer is yes for the right patient population.

Thank you for being more objective.

 

[sevoflurane]

No, the midlevel move would be to simply label them allergic to bupivicaine, which was my point. And I'm willing to bet that will be part of the conversation this patient has with their "provider" at every point in the future. How do you know - right now - it wasn't an amide allergy? Rare, but it happens. Willing to bet that without further testing that "local anesthetic" is added to the patient's allergy list?

He's not allergic to regular Bupivicaine because he's had it before.

The timing is interesting. He probably had a Type IV hypersensitivity reaction.

Which is what is confusing to some of us.

I'm not full on negative about exparel. I think it does work... just not as good as Pacira claims (72 hrs.) As blade pointed out, the difference btw/ $3 and $280 is substantial. Multiply that by what hospitals usually charge the patient and the cost difference is even larger. Some of our orthopods have gone back to the cocktail as they did not detect a noticeable difference between both groups (we were not involved in this decision).

Regarding the "one" reaction I've had... well I can positively say I've used buckets more plain marcaine than I have exparel... and I've never seen anything like this before.

Between the cost, the conflicting studies, the FDA warning letter and my personal experience, I'm sitting this one out for now... at least until the dust settles.

At one time everyone thought that intraarticular catheters were the next best thing since slice bread...

http://www.youhavealawyer.com/pain-pump/pagcl-condrolysis/

I'm by no means saying that this is where exparel is going, but histroy does tend to repeat itself.

 

[Noyac]

My patient satisfaction scores utilizing Tap blocks as described by Hebbard with Exparel plus Decadron is close to that of Epidural analgesia without any of the postop issues/hassles. Both Surgeons and Patients are extremely satisfied with the technique.

So you guys separate your pt satisfaction scores out individually?

 

[Noyac]

I'm not angry. Think of how many bottles of Exparel have been used by Physicians since its release. How many case reports of severe allergy exist? Or, what about those large trials utilizing Exparel or my hospital where over 1,000 bottles have been used? I'm not aware of a single reaction to the drug except the one you posted. So, this is a 1 in 100,000 type event or even rarer. I'm not dismissing it or saying that it can't happen to one of my patients but rather it is a rare event.

It's not 1/100,000. We all know it isn't. Nothing is really. Anesthesia mortality claims around 1/2-300,000 risk. We all know this is BS. This came from a study looking at ASA 1&2's in the Harvard system. I don't know about you guys but I would think all comers should count. Even 4's if the cause of death were anesthesia related. And also, it only counted those that died in the OR and we all know this is BS as well. You can make it to the ICU and still die of an anesthesia complication. Just look at Joan Rivers. This study would not have counted her.

So All events are not reported as they should be. But the ASA is trying to improve this with its adverse events registry.

So Exparel can't claim a 1/100,000 adverse event record.

 

[epidural man]

Hey you smart folks - teach me something.

To have an allergic reaction - (type I or IV), the body has to have seen the allergen previously. If this was the first time this patient had Exparel, how did they have an allergic reaction?

Second, how is a lipid layer an allergen? The lipid layer seen in exparel is presumably made up of the same lipid layer the patient has all over the body. I'm very confused how this could happen.

Please explain.

 

[sevoflurane]

What's the difference between an anaphylactic and anaphylactoid reaction...?

 

[deleted162650]

To have an allergic reaction - (type I or IV), the body has to have seen the allergen previously.

I agree that's true for Type 1 reactions, but I'm not sure that's true for type 4. Poison oak/ivy causes a Type 4 hypersensitivity reaction (which really sucks by the way) and I'm pretty sure that it will happen on first exposure. I would appreciate some education on this as well. Where are all the allergy/immunology lurkers at?

 

[BuzzPhreed]

Well, you don't necessarily have to have a prior exposure, especially in a long-acting substance. Just time for the body to react.

Second, how is a lipid layer an allergen?

There's this:

http://en.wikipedia.org/wiki/Hapten

That's how PABA (a small lipophilic molecule) elicits an immune hypersentsitivity reaction. It's also how halothane is thought to attack the liver.

 

[Noyac]

Simple explanation, if you want more then look it up.

anaphylaxis - antigen bound by IgE leading to mast cell and basophils response.

Anaphylactoid- non (IgE) immunologic reaction leading to degranulation of mast cell and basophils. Think IV contract.

 

[Mman]

Pain relief studies bring up interesting (and sometimes strong viewpoints). Is a TAP block a nice thing? Sure. For things like an umbilical hernia it can help provide some nice pain relief. But it's not a huge deal. They don't go from 10/10 pain to 1/10 pain. It also doesn't last that long. We make a big deal out of pain control for a period of time, but no matter what local we use it only covers a brief portion of the duration of time the patient will hurt for. Patients hurt for days and weeks after surgery to varying degrees.

In my opinion and experience, post op pain tends to decrease exponentially over time. Good pain relief the first hour (or two or six) is really important. But 12 hours later they don't need as much. 24 hours they need less. 48 hours they need even less. 96 hours later they need even less. And so on. This holds true for almost every kind of operation.

So is a local anesthetic that increases the block from 24 hours to 48 hours relevant to a clinical outcome for a patient? Probably not. You aren't seeing decreased mortality from it. You aren't seeing shortened hospital LOS. You aren't seeing decreased cardiac events. You aren't even really seeing a big decrease in opioid side effects since the difference is only from 25-48 hours (first 24 hours and everything from 48+ are identical). And at 6 month follow up on that patient, you probably won't even see any patient satisfaction difference because they won't remember whether they were hurting again on POD #2 or #3, just that they hurt again when it wore off.


Exparel is a neat trick for drug delivery. Unfortunately it's an expensive trick. And in a world where hospitals across the country are facing massive deficits in the next decade, it might not be feasible for a hospital that wants to continue to be open for business.

 

[BLADEMDA]

At least 2 dozen patients have come through my hospital for REVISION hernia surgeries of all types. The vast majority (90% plus) reported significantly lower pain scores and higher patient satisfaction scores with Tap blocks utilizing Exparel vs local infiltration by the surgeon. These individuals were tracked and questionnaires were sent out.

In addition, LOS was reduced by ONE Day for this group of patients who had TAP blocks with Exparel. Exparel is cost effective in a high risk subgroup of patients undergoing revision hernia surgery.

 

[Mman]

At least 2 dozen patients have come through my hospital for REVISION hernia surgeries of all types. The vast majority (90% plus) reported significantly lower pain scores and higher patient satisfaction scores with Tap blocks utilizing Exparel vs local infiltration by the surgeon. These individuals were tracked and questionnaires were sent out.

In addition, LOS was reduced by ONE Day for this group of patients who had TAP blocks with Exparel. Exparel is cost effective in a high risk subgroup of patients undergoing revision hernia surgery.

You don't have that kind of data. Nobody does. Nobody has 6 month out satisfaction scores from pain blocks for groups of patients that had TAP blocks with bupivicaine and then with exparel.

And you can't reduce hospital LOS by an average of 1 day per patient for outpatient procedures or 23 hour obs procedures.

 

[epidural man]

On-q pump costs over $300 dollars. The epidural kit costs $20. The management of catheters are a pain in the arse.

Exparel is 2/3ds the cost of a catheter.

 

[Noyac]

I don't find epidural catheters a PITA. I find that they work well. Real well. Better than TAP blocks from what I understsnd.

 

[epidural man]

Noyac,

No doubt epidurals work better than TAPS. Nothing beats a well placed, well maintained, appropriately dosed thoracic epidural.

They are more work though..that is for sure. TEA has a high failure rate as well.

I was more referring to peripheral nerve catheters - or wound catheters.

 

[BLADEMDA]

You don't have that kind of data. Nobody does. Nobody has 6 month out satisfaction scores from pain blocks for groups of patients that had TAP blocks with bupivicaine and then with exparel.

And you can't reduce hospital LOS by an average of 1 day per patient for outpatient procedures or 23 hour obs procedures.

Did you read my post? I said REVISION hernia surgery.

 

[Noyac]

Epidural man,
I didn't realize you were talking about peripheral cath's. I would agree with that. We actually don't do that many peripheral cath's any longer. They really fell out of favor in my facility.

 

[Mman]

Did you read my post? I said REVISION hernia surgery.

Yes. I read it. How long do you think those patients stay in the hospital? Vast majority of ours are out the door by the next morning.

 

[sleepallday]

.

 

[Planktonmd]

Epidural man,
I didn't realize you were talking about peripheral cath's. I would agree with that. We actually don't do that many peripheral cath's any longer. They really fell out of favor in my facility.

I think they are falling out of favor everywhere