$60M Lumbar TFESI Settlement

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lobelsteve said:
Betamethasone is a particulate. Rop? In an epidural for pain? Nuts. See Tiso study.
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Betamethasone sodium. Should have clarified.

Yes, betamethasone acetate is particulate. Sodium is not.

To be clear, I'm obviously not defending this case. Just stating what I heard happened.
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hopefulgasman said:
Ropi, bupi? Y’all want your patients admitted because they can’t walk all day?

Betamethasone is a particulate

Dex becomes a particulate when mixed with ropi….
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Yep. All that stuff. That’s why I use bupi or lido only in cervical RFA, bc I always use dex and it’s basically now a particulate if ropi is given. Beta is absolutely a particulate, with at least one study measuring very large aggregates.

If you use local in an ESI I’d recommend lidocaine only, unless they’ve got a raging hot herniation or they’re already in a WC. If an acute HNP I think bupi 0.25% is good.
 
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bedrock said:
Please show me the study that shows dex becomes a particulate when mixed with Ropi.

It happens with betamethasone yes, but dex?
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This is literally an IPSIS fact finder discussed by Zack McCormick and others ad nauseam.

Myth: Corticosteroids can be mixed with local anesthetics for injection during interventional spine procedures without concern for adverse consequences due to the interactions between two agents combined for injection.

Fact: There is in vitro evidence that ropivacaine precipitates crystal formation larger than the diameter of an arteriole when combined with either dexamethasone or betamethasone.

Hwang H, Park R, Lee WK, Leigh I-H, Lee JJ, Chung SG, Lim C, Park SJ, Kim K. Crystallization of local anesthetics when mixed with corticosteroid solutions. Ann Rehabil Med 2016;40:21-27. 3. Watkins TW, Dupre S, Coucher JR. Ropivacaine and dexamethasone: a potentially dangerous combination for therapeutic pain injections. J Med Imaging Rad Oncology 2015;59:571-577.
 
hopefulgasman said:
This is literally an IPSIS fact finder discussed by Zack McCormick and others ad nauseam.

Myth: Corticosteroids can be mixed with local anesthetics for injection during interventional spine procedures without concern for adverse consequences due to the interactions between two agents combined for injection.

Fact: There is in vitro evidence that ropivacaine precipitates crystal formation larger than the diameter of an arteriole when combined with either dexamethasone or betamethasone.

Hwang H, Park R, Lee WK, Leigh I-H, Lee JJ, Chung SG, Lim C, Park SJ, Kim K. Crystallization of local anesthetics when mixed with corticosteroid solutions. Ann Rehabil Med 2016;40:21-27. 3. Watkins TW, Dupre S, Coucher JR. Ropivacaine and dexamethasone: a potentially dangerous combination for therapeutic pain injections. J Med Imaging Rad Oncology 2015;59:571-577.
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what about lidocaine? Any evidence that this causes crystallization? I don't mix them in the same syringe but I will not infrequently inject some local through the needle before injecting the steroid/PFNS mixture
 
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25 g needle. Dye. Dex. Lateral and AP.

No idea if crystallization is a real risk. Anyone with real world experience? If it was a real risk, would we observe crystallization within our syringes, or is it too small to observe? If the crystals do form, would they rapidly dissolve when exposed to blood flow? Is it an issue at body temperature?
 
1 Up said:
25 g needle. Dye. Dex. Lateral and AP.

No idea if crystallization is a real risk. Anyone with real world experience? If it was a real risk, would we observe crystallization within our syringes, or is it too small to observe? If the crystals do form, would they rapidly dissolve when exposed to blood flow? Is it an issue at body temperature?
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Your questions about crystallization are good ones… and given what literature does exist about it, it seems the safest option is to assume that it’s real. It’s pretty unlikely any of us could see small crystallizations in a syringe as we’re talking about something in the realm of microns. Data suggests that even dex+ropi can form crystals bigger than a RBC…which to me suggests it’s plausible the small crystals may still be big enough to cause an occlusion.
 
has there been any literature on complications of using kenalog/depo via interlaminar approach (i'm not talking about injecting deep etc, but a vascular complication from particulate)
 
Interesting discussion. Some of our disagreements might be based on our unique pt populations. If I had acute radics, I would be more inclined to add local and possibly TF vs IL route. I also rarely have NS asking for a specific level.

My practice is all chronic pain, with ESI being my number one most satisfied patients. 95% IL, 95% dex, no local, no sedation, never a question of safety being prioritized. If dex doesn't work, I review the risks and offer depo.

I won't use anything that says, "DO NOT USE" on the vial.
 
To play the devils advocate when I trained we put one cc. 0.25 % bupi with the dex. Diluted with ns. Never one patient that couldnt walk all day or even for a few mintues. I’m sure there were some falls but my patients fall all the time with no injection as well so who knows.
 
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au bon pain said:
While it sounds like there’s some red flags in this case, the bottom line is that unfortunate **** can happen to anyone—patient and doc alike.

I would love it if Trump started to push for federal-level tort protection for doctors as well as some sort of national risk pool that would be used to review +/- pay out suits that aren’t lowered on appeal.
This kind of thing is waaaay overdue and right now is the ideal time to make it happen while Republicans have both houses and the White House. Democrats will never do this.
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Agree. I’m glad you see the distinction.
 
Baron Samedi said:
To be honest now that I've been in this field for a while, I don't think I would ever get a spine injection.
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I remember tenesma saying that about having a cesi, which I can somewhat understand. Not as relevant for lumbar cases.

But if you personally had severe radicular pain unresponsive to PT+ NSAIDS/neuropathic meds, would you then 1- just be miserable for 6 months, or 2-have surgery which carries more risk than an ILESI with depo or TFESI w dex?
 
bedrock said:
I remember tenesma saying that about having a cesi, which I can somewhat understand. Not as relevant for lumbar cases.

But if you personally had severe radicular pain unresponsive to PT+ NSAIDS/neuropathic meds, would you then 1- just be miserable for 6 months, or 2-have surgery which carries more risk than an ILESI with depo or TFESI w dex?
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I'll take the esi. At least I'll try it.
 
bedrock said:
I remember tenesma saying that about having a cesi, which I can somewhat understand. Not as relevant for lumbar cases.

But if you personally had severe radicular pain unresponsive to PT+ NSAIDS/neuropathic meds, would you then 1- just be miserable for 6 months, or 2-have surgery which carries more risk than an ILESI with depo or TFESI w dex?
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I had a really bad cervical radic from an acute herniated disc. Was offered a cesi but declined. Eventually I developed severe motor weakness and ended up with surgery anyways. No way was I going to get a cesi.

456.jpg
 
Why not? I don’t understand that decision. That neck MRI probably won’t respond to a CESI, but I’d have gotten one as a life raft while I wait.

I would not let anyone in my practice inject my neck, that’s for sure. Group next door maybe, older guy across town who just paid several million to the govt, heck no…

I’d prob have to drive to get one but I’d do it.
 
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MitchLevi said:
I would not let anyone in my practice inject my neck, that’s for sure. Group next door maybe, older guy across town who just paid several million to the govt, heck no…

I’d prob have to drive to get one but I’d do it.
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I just did a cesi for one of my partners. Forgot to tell him to increase his disability rider before we did it lol
 
MitchLevi said:
Why not? I don’t understand that decision. That neck MRI probably won’t respond to a CESI, but I’d have gotten one as a life raft while I wait.

I would not let anyone in my practice inject my neck, that’s for sure. Group next door maybe, older guy across town who just paid several million to the govt, heck no…

I’d prob have to drive to get one but I’d do it.
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I was just going to wait it out with some gabapentin and PT but then the motor weakness came on really suddenly. Didn't have to wait for surgery, one of those ER visit and same day OR deals.
 
au bon pain said:
lol I was literally thinking the exact same thing… seems like even an ipsilateral 2 level should be an almost-never thing
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You’re reaching there. Plenty of patients do well with unilateral 2 level TFESI, particularly as follow-up to a first ESI with only ok relief
 
Lots of Mac, on both coasts. We really only have problems here with patients who move from California and want to be “knocked out”. Cedars Sinai does MAC for routine pain procedures.
 
BobBarker said:
Lots of Mac, on both coasts. We really only have problems here with patients who move from California and want to be “knocked out”. Cedars Sinai does MAC for routine pain procedures.
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People move FROM Los Angeles TO Oklahoma?

I apologize if I have you and cowboydoc confused. In my mind I can’t seem to separate you two
 
Routinely for early retirement. Yes, CA to OK. It has been happening for over 25 years. Even in my very rough hometown. The Californians would just pick a house off the internet for 20% what it would cost in California and pay cash for it.
 
Snowmen96 said:
Pretty much all the studies that have compared Dex to particulates have shown Dex to be non-inferior for lumbar TFESI. The best designed study was actually really close to showing Dex being superior to particulates.

pubmed.ncbi.nlm.nih.gov

The noninferiority of the nonparticulate steroid dexamethasone vs the particulate steroids betamethasone and triamcinolone in lumbar transforaminal epidural steroid injections - PubMed

This retrospective observational study reveals no evidence that dexamethasone is less effective than particulate steroids in lumbar TFESIs performed for radicular pain with or without radiculopathy.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
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You’re new here, so I will repost some information the older docs have seen before.

1- no statistically valid study has proven dex to be more effective than particulate.
2- The only clinical situation for which dex has been proven to be close to particulate is for ACUTE new disc herniations with radiculopathy. Not quite as good as particulate but dex did ok, and I have no problem with docs who only offer TFESI with dex in that clinical scenario. Unfortunately acute new discs causing new hot radiculopathy are relatively uncommon in most pain practices.
3- There has never been a prospective study demonstrating dex lasts anywhere near as long as particulate for the two spine pathologies pain physicians treat most commonly with epidurals——- ( lumbar stenosis with claudication and recurrent lumbar radic due to chronic degenerative disc bulge +/- mild-mod stenosis)
3b- The pathophysiology of stenosis and degenerative disc bulge with mild-mod stenosis is NOT the same as an acute HD.

Five out of six lumbar epidurals performed in most pain practices are for the two pathologies listed in #3, NOT acute radiculopathy from new disc herniation, listed in #2.

You are not proving optimal care to #3 patients if you only offer ILESI or TFESI with dex. Much of the time dex provides significantly shorter duration of relief for those clinical pathologies compared to depo.

You need to offer lumbar ILESI and caudals with depo, or many, many of your patients will have unnecessary surgery, due to you. It is fine if you want to start with a dex TFESI. However, you are doing your patients a disservice if you then fail to provide an ILESI or Caudal with depo as the second epidural if the first ESI with dex fails to provide the patient with at least 3-4 months of relief.
 
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I have a colleague who's been around a while longer than I have that does all lumbar TFESI with Kenalog. Also fwiw two needles for two joints in MBB (with steroid), TPI with steroid, occasional cervical ILESI at C5-6. We're both employed but he functions in a superior leadership type role. Probably not my place, but...would you say something?
 
GatorCHOMPions said:
I have a colleague who's been around a while longer than I have that does all lumbar TFESI with Kenalog. Also fwiw two needles for two joints in MBB (with steroid), TPI with steroid, occasional cervical ILESI at C5-6. We're both employed but he functions in a superior leadership type role. Probably not my place, but...would you say something?
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And piss him off?

Have you ever met a pain physician who wan't smarter than everyone else in their field?
Have you ever met a pain physician that was not the world's greatest?

We are all a bunch of grandiose a-holes and by the grace of god be thankful that the body count is higher.
 
GatorCHOMPions said:
I have a colleague who's been around a while longer than I have that does all lumbar TFESI with Kenalog. Also fwiw two needles for two joints in MBB (with steroid), TPI with steroid, occasional cervical ILESI at C5-6. We're both employed but he functions in a superior leadership type role. Probably not my place, but...would you say something?
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Not worth it. Leave it alone unless he’s creating documentation or billing errors.
 
GatorCHOMPions said:
I have a colleague who's been around a while longer than I have that does all lumbar TFESI with Kenalog. Also fwiw two needles for two joints in MBB (with steroid), TPI with steroid, occasional cervical ILESI at C5-6. We're both employed but he functions in a superior leadership type role. Probably not my place, but...would you say something?
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You going to drop that list on him at the water cooler? He's not changing his ways, and you don't employ him, so just let it be unless you want drama
 
GatorCHOMPions said:
I have a colleague who's been around a while longer than I have that does all lumbar TFESI with Kenalog. Also fwiw two needles for two joints in MBB (with steroid), TPI with steroid, occasional cervical ILESI at C5-6. We're both employed but he functions in a superior leadership type role. Probably not my place, but...would you say something?
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Hard for you to address directly to him, but since you’re both employed, you could pull the relevant Medicare LCDs (what you described is clearly in violation of the facet joint LCD, and the new TPI LCD) and send them to your billers. Tell them you’ve noticed there’s a difference in the way you two are coding and want to make sure you aren’t missing something. Unfortunately, those are the wrong but not terribly dangerous ones.

C5-6 ESIs and Kenalog TFESIs are a bad idea risk and liability-wise but not explicitly against coverage guidelines, so much harder to convince someone who’s been doing it that way for years that he should change.
 
bedrock said:
You’re reaching there. Plenty of patients do well with unilateral 2 level TFESI, particularly as follow-up to a first ESI with only ok relief
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Yeah perhaps my brush sounds too broad and is unclear. There’s a big private equity chain of practices around me, and these guys seem capable of only doing 2 level TFESI.
Flair of a chronic radic with clear single dermatome? 2 level TFESI
LSS w/NC? 2 level TFESI
Axial LBP? 2 level TFESI
…you get the idea. I see a lot of patients who leave their practice and when they ask me for the same injections to be repeated (that often only yielded a few weeks of relief) several have asked me why I wouldn’t just do the same thing again… I virtually never speak ill of other doctors with patients (including in these situations), but I hate these conversations and don’t want to make patients feel bad for being recipient of a wallet biopsy to appease PE overlords.

But I can understand why someone would offer a unilateral 2 level TFESI. However, as you say, I do think it should rarely be first-line as there’s no prospective data I’m aware of showing 2 level TFESI > 1 level TFESI (and the retrospective data is actually pretty limited too).
 
Getting past the absurdity of doing a bilateral 2 level TFESI, I’m actually impressed the doc was able to get this approved by insurance. Cash pay maybe?

Anecdotally I’ve had some success with what I call the “sandwich technique”. Two level TFESI (above and below) a HNP**

Example: HNP at L5-S1, initial L5-S1 TFESI didn’t work well or I’m worried about sticking the disc I’ll do a l4-5 and S1 tfesi.

Haven’t seen any specific literature on this but I’d imagine several of you guys probably do this as well
 
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