Exparel to get nerve block indication

Discussion in 'Anesthesiology' started by Oggg, 05.19.14.

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  1. Oggg

    Oggg 2+ Year Member

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    Pacira Pharmaceuticals, Inc. (PCRX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a nerve block indication for EXPAREL® (bupivacaine liposome injectable suspension). The sNDA is based on positive data from a Phase 3 study assessing the safety and efficacy of EXPAREL in femoral nerve block for total knee arthroplasty, and will also include additional safety data from a Phase 3 study of EXPAREL used to perform an intercostal nerve block for thoracotomy.

    The timeline for review of the sNDA, under the Prescription Drug User Fee Act (PDUFA), is 10 months. If the FDA accepts the sNDA filing, a PDUFA target date of March 5, 2015 is expected.
     
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  3. Mman

    Mman Senior Member 10+ Year Member

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    I'm still waiting for Suggamadex to get that approval....
     
  4. Outrigger

    Outrigger 5+ Year Member

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    Is there any added benefit to using exparel in a femoral block versus the surgeon injecting the joint?
     
  5. BuzzPhreed

    BuzzPhreed

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    Blocking the femoral nerve where?

    I think they are too late with the classic FNB indication if that's what they're going for. The ortho surgeons are moving more towards adductor canal block for TKA because it spares the vastus lateralis and preserves knee extension which is necessary for early ambulation. Extending the block for longer duration with a liposomal agent will make the timing more unpredictable. Regardless, if you put a little dexamethasone in a single shot you reliably get 24 hours. It costs far less than Exparel. In other words why do we need to reinvent the wheel? They may get the indication via the supplemental NDA but I think it's pointless.

    It's not a game changer. It's money not well spent for the PDUFA review.
     
  6. Scumlee13

    Scumlee13 2+ Year Member

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    It was a safety study on the femoral PNB. Of course you could probably use it on the adductor canal and get similar efficacy.

    Regarding early ambulation and sparing the vastus lateral, I've noticed relatively preserved motor function been with the femoral nerve blockade with Exparel.

    I think it is a game changer and I have seen the 72 hr analgesic effects in many patients. Addition of decadron doesn't extended the block as long.
     
  7. BuzzPhreed

    BuzzPhreed

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    I would only think it was a 'game changer' if I either worked for or owned stock in Pacira. Or both.
     
  8. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    I do not own stock in Pacira or work for them. I have no affiliation with the company whatsoever. That said, I like Exparel except for its $280 cost. I use it regularly for BD Tap Blocks with excellent results. I'd like to use it selectively for other blocks but am reluctant due to the lack of FDA Approval.

    Once Exparel gets FDA approval I will sparingly use it for Nerve Blocks and others will join in using it for TAP blocks. Hence, I disagree the Secondary application is a waste of time and money. Pacira sales will increase by 50% once the FDA gives its stamp of approval. Many more studies will be performed without the same medico-legal risk once the FDA approves the drug for BROAD merve block application.
     
  9. BuzzPhreed

    BuzzPhreed

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    I doubt it. We'll see.
    A TAP block doesn't immobilize the patient for 3 days.

    If it will provide analgesia without a motor block that's one thing. If it knocks out the vastus lateralis like I said before the orthopods are going to hate it. We'll see how far you get if your block lasts three days... motor block that is.
     
  10. caligas

    caligas ASA Member 2+ Year Member

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    No. It makes more sense to use the drug at the surgical site and avoid the time and risk of doing a nerve block.
     
  11. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    Our surgeons are doing intrarticular injection with Exparel plus I provide an adductor canal block.
     
  12. Oggg

    Oggg 2+ Year Member

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    I think Ilfeld came out with a pretty crappy study of FNB with Exparel on some healthy volunteers and showed that it worked, it was safe, did not cause a lot of motor block, but didn't last that long either. Blade anecdotally has said Exparel plus dexamethasone is longer acting than bupiv with dexamethasone. I'd expect more motor block as well.

    It seems like Exparel and dexamethasone would be a perfect fit for adductor canal blocks, intercostal or thoracic paravertebral blocks, upper arm blocks (for painful stuff like total shoulders, maybe rotator cuff repair) and TAP/quadratus blocks. I'd wait for someone to do a study on interscalene with Exparel, but the rest seem like no brainers. Obviously you wouldn't do a long lasting motor block on someone who needs early rehab, but there's still a ton of people who could benefit.
     
  13. Noyac

    Noyac ASA Member SDN Advisor 10+ Year Member

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    The cost is inhibitory. We can't even get it due to cost.
    Plus, I will never place a block that lasts greater than 30 hrs. WTF, that is crazy in my mind. Pts need to mobilize.
    TAP block maybe. Adductor canal maybe (if it ever proves to be better than a 24 hr FNB). But I want nothing to do with a block that restricts motor function much more than 24 hrs.
     
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  14. sevoflurane

    sevoflurane Ride 10+ Year Member

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    No doubt. Motor block lasting more than 30ish hours is counterproductive and I'm not sure patients would like the spagghetti leg feeling for more than that.
     
  15. Oggg

    Oggg 2+ Year Member

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    There are plenty of blocks besides FNB and sciatic.
     
  16. RxBoy

    RxBoy ASA Member 7+ Year Member

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    PCRX stock looks pretty amazing. 11% increase one month, 166% in one year, 670% in 2 years. Steady increases without much volatility. Of course historical trends prove nothing about future trends. Plus pharm stocks are usually pretty big risk.

    What do you wallstreet slickers think?
     
  17. Noyac

    Noyac ASA Member SDN Advisor 10+ Year Member

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    Name one!
     
  18. pgg

    pgg Laugh at me, will they? SDN Moderator 10+ Year Member

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    http://forums.studentdoctor.net/threads/pacera.979881/
    http://forums.studentdoctor.net/threads/stock-in-pacira-pharmaceuticals-pcrx.989585/

    I didn't and won't buy it. (I just don't pick any stocks.)
     
  19. RxBoy

    RxBoy ASA Member 7+ Year Member

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    Damn, blade wanted to buy it when it was 16.... Now its in the 70's.
     
  20. sevoflurane

    sevoflurane Ride 10+ Year Member

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    Gilead Sciences and Pacira are my home runs in the biotech sector for the past couple of years.

    I have family members at the forfront of Sovaldi production and manufacturing. It doesn't treat hep C... it cures it for $1000 a pill or $84,000 a treatment course. Expensive, yes... but still cheaper than living with hep C.

    [​IMG]
     
  21. Mman

    Mman Senior Member 10+ Year Member

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    I don't buy speculative stocks. Buying a stock with a market cap of $2.8 Billion that has lost money every year and is not paying a dividend is not a conservative investment but is pure speculation. Might it work out? Sure. But statistically people that play that guessing game with stocks have lost money in comparison to the overall returns of the S&P 500 over the long haul. I'm in it for the long haul and I don't need to get lucky on stocks to fund my retirement so it isn't my cup of tea for investment.

    If you had play money you didn't care about I could see how it could be an interesting speculation since the drug could make the company a lot of money in the future. It appears, however, that a lot of those potential future gains are already priced into what has been a poorly performing company's stock price. I mean last year they lost $64 million. The year before, $52 million, then $43M, then $27M. I mean they keep going further in the hole every year. Not exactly the track record I'm looking to get in on with my money as buying a part of that company.
     
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  22. RxBoy

    RxBoy ASA Member 7+ Year Member

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    This is the main reason im not going to invest, even from a purely speculative stand point. Id be jumping on the train too late to make those big returns. The risk is still high but the yield will be much lower.

    I invest 80% of my stocks into voo. A vanguard s&p 500 index fund. I will be longing this one for 20+ years.
     
  23. napman

    napman

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    The incidence of perminent nerve damage after peripheral nerve block is so rare (reported to be 1.5 in 10,000 patients ) that the study in 100 pts is going to be grossly underpowered to show that EXPAREL is safe for peripheral nerve block.

    I routinely do TAP blocks fo hysterectomies with 15cc of 0.5% bupivacane, 5cc of 2% lidocane and 5mg of dexamethasone on each side and I get significant amount of opioid sparing for a good 30 hours. I am not still convinced that EXPEREL is worth the cost and I am not going to use it for peripheral nerve blocks anytime soon.

    http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=1824783&highlight=
     
  24. BuzzPhreed

    BuzzPhreed

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    My opinion? Let the surgeons play with Exparel. This is not a medication for anesthesiology.

    Anyone remember what happened a few years back with DepoDur? Came and went like a fart in a windstorm. Anyone still using that stuff? If you are have you had to admit anyone intubated to the ICU yet? Another genius product from our friends at Pacira.
     
  25. BuzzPhreed

    BuzzPhreed

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    Is anyone really still doing interscalenes? I'd only do one of these now if I couldn't find an ultrasound machine or it was broken.
     
  26. Arch Guillotti

    Arch Guillotti Senior Member Lifetime Donor SDN Administrator 10+ Year Member

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    I do them sometimes. Why not?
     
  27. imfrankie

    imfrankie Anesthesiologist 5+ Year Member

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    Pacira sales will increase by 50% once the FDA gives its stamp of approval. Many more studies will be performed without the same medico-legal risk once the FDA approves the drug for BROAD merve block application.[/QUOTE]

    How long you have to run an intralipid drip if you get cardiac toxicity with that stuff. Maybe I'll short it.
     
  28. Hawaiian Bruin

    Hawaiian Bruin Breaking Good 10+ Year Member

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    Why are interscalene and ultrasound mutually exclusive?

    I like IS for shoulders. Get c5, spare the forearm.
     
  29. Mman

    Mman Senior Member 10+ Year Member

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    Interscalene is mildly better than supraclavicular for the shoulder with the ultrasound. Slightly more likely to get the suprascapular nerve which comes off the superior trunk.

    I'm not going to quibble with someone who defaults to a supraclavicular for all comers in the upper extremity, but interscalene is slightly more likely to give you perfect analgesia postop from shoulder surgery.
     
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  30. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    How long you have to run an intralipid drip if you get cardiac toxicity with that stuff. Maybe I'll short it.[/QUOTE]


    I've used over 200 bottles of Exparel so far in a wide range of patients 40kg-165kg with ZERO complications or issues. In addition, our Surgeons have used over 100 bottles of Exparel for local injection (knee, hip, subQ, etc) with zero complications.

    So, short the stock all you want but be prepared to lose money as the drug is safe and effective.
     
  31. pgg

    pgg Laugh at me, will they? SDN Moderator 10+ Year Member

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    I wonder how many bottles of rapacuronium were used without complications or issues before it got pulled from the market.
     
  32. Noyac

    Noyac ASA Member SDN Advisor 10+ Year Member

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    What are you talking about?
     
  33. Noyac

    Noyac ASA Member SDN Advisor 10+ Year Member

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    Oh yeah, rapacuronium. I liked that stuff. Never had a complication with it.
     
  34. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    Anesthesiology. 2005 Jan;102(1):117-24.
    Rapacuronium preferentially antagonizes the function of M2 versus M3 muscarinic receptors in guinea pig airway smooth muscle.
    Jooste E1, Zhang Y, Emala CW.
    Author information

    Abstract
    BACKGROUND:
    Rapacuronium, a nondepolarizing muscle relaxant that was proposed as a replacement for succinylcholine for rapid intubation, was withdrawn from clinical use as a result of fatal bronchospasm, but the mechanism of this effect is not known. Preferential antagonism of presynaptic M2 muscarinic receptors versus postsynpatic M3 muscarinic receptors can facilitate bronchoconstriction. The authors questioned whether rapacuronium preferentially antagonized M2 versus M3 muscarinic receptors in intact airway.

    METHODS:
    Guinea pig tracheal rings were suspended in organ baths and muscle relaxants' antagonism of prejunctional M2 muscarinic autoreceptors was evaluated by augmentation of muscle contraction elicited by electrical field stimulation. Muscle relaxants' antagonism of postjunctional M3 muscarinic receptors was assessed by attenuation of muscle contraction elicited by acetylcholine.

    RESULTS:
    Rapacuronium displayed a 50-fold higher affinity for antagonism of the M2 versus M3 muscarinic receptor. Moreover, its affinity for the M2 but not the M3 receptor was within concentrations achieved clinically. In addition, rapacuronium caused an increase in baseline tone of airway smooth muscle that was antagonized by atropine but not by previous depletion of nonadrenergic noncholinergic neurotransmitters or by inhibitors of histamine receptors, tachykinin receptors, leukotriene receptors, or calcium channels.

    CONCLUSION:
    These findings are consistent with the hypothesis that rapacuronium may precipitate bronchoconstriction by selective antagonism of the M2 muscarinic receptor on parasympathetic nerves, enhancing acetylcholine release to act upon unopposed M3 muscarinic receptors on airway muscle. An additional mechanism of rapacuronium-induced bronchoconstriction is suggested by increases in baseline muscle tension.
     
  35. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    Although the overall reported incidence of bronchospasm (in controlled trials) after rapacuronium and succinylcholine were 3.2 and 2.1%, respectively (data from Organon Inc., West Orange, NJ), others 1 noted 18 incidents of such events (10.7%) after rapacuronium compared with 7 cases (4.1%) after succinylcholine. In the latter study, only one patient in the rapacuronium group, who had a history of obstructive airway disease, had severe bronchospasm after intubation. 1 Our patient had severe bronchospasm after rapacuronium despite the facts that she was not asthmatic and that she received propofol for induction. Kahwaji et al.2 reported two serious adverse effects (tachycardia and bronchospasm) that occurred in a 29-yr-old, 100-kg man with American Society of Anesthesiologists physical status I within 30 s of administration of 2.0 mg/kg rapacuronium.

    Rapacuronium may release histamine and produce slight changes in blood pressure and heart rate after administration. 3 However, it seems that the bronchospasm noted with rapacuronium is mediated viamechanisms that do not seem to be related to histamine release. 3 The affinity of neuromuscular blockers for the muscarinic receptor seems to have some influence on neural control of airway caliber. Pancuronium and atracurium (but not vecuronium) were found to enhance the increases in pulmonary resistance induced by vagus nerve stimulation, probably by blocking prejunctional muscarinic receptors (M2) that physiologically inhibit vagally mediated increases in pulmonary resistance. 4,5 Blockage of M3 muscarinic receptors on airway smooth muscle inhibits vagally induced bronchoconstriction. 5 Pancuronium and gallamine had affinities for the M2 muscarinic receptor within the clinical dose range. 6 The affinity of rapacuronium for muscarinic receptors has not been studied. Therefore, there is insufficient evidence to make a definite statement on how rapacuronium induces bronchospasm. It seems prudent, therefore, to avoid using rapacuronium in patients with asthma or airway hyperreactivity
     
  36. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    So far my incidence of complications from Exparel is ZERO with ZERO reported severe incidents in the literature. In fact, I haven't read even one case report of LAST from Exparel but I'm sure someone will eventually dump the whole bottle intravenous.
     
  37. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    Exparel: a New, Long-lasting Local Anesthetic that Decreases Postoperative Pain after Hip or Knee Replacement Surgery
    Categories: Exparel,Hip Replacement Surgery,Knee Replacement Surgery,News

    As more and more people have hip and knee replacement surgery, postoperative pain management treatments and drugs, as well as prostheses and surgical techniques, continue to be refined. New and longer-lasting drugs with decreased side effects are being developed to help patients.

    In a previous blog, Managing Postoperative Pain, I discussed my philosophy and the approach we take at the Leone Center for Orthopedic care to decrease post-operative pain. Our focus and emphasis is to stay ahead of the pain curve by eliminating it before it starts. We preempt and diminish pain by using a multi-modal approach with less emphasis on narcotics, which historically has been the central pillar to treat post-operative pain. With this refined multi-modal approach, we’ve been able to avoid many of the complications which plague patients post-operatively, including nausea, vomiting, constipation, confusion, and “feeling out of sorts,” just to name a few. Because of our emphasis on managing pain, especially in the early post-operative period, patients mobilize sooner, which is safer for their overall health. Their physical therapy also is facilitated which is critical for a full and optimal recovery.

    One aspect of the approach I use to prevent and decrease pain after surgery is to infiltrate the tissues around the hip or knee replacement with a solution that includes a local anesthetic called bupivacaine (Marcaine), morphine sulphate (a narcotic), and Toradol (an intravenous NSAID). This combination of medications has resulted in remarkably decreased pain for patients during the early post-operative period.

    Bupivacaine is a time-honored local anesthetic, which is both effective and predicable, but its anesthetic effect is not long-lasting. When combined with epinephrine, which causes the blood vessels in that area to constrict, and the other agents, patients experience much less pain for the first 18 to 24 hours after surgery.

    Recently, I added a new pain medication called Exparel to the pain-management “cocktail” I use to treat my patients. Exparel is injected separately into the tissues surrounding the knee or hip during surgery and its effects are much longer-lasting.

    The benefits of Exparel are based on a new drug delivery system called DepoFoam. This new technology encapsulates the bupivacaine molecule in a fat delivery (liposomal) system that then breaks down slowly in the body and allows the extended release of the bupivacaine over 48 to 96 hours. Because the fatty molecule that surrounds the bupivacaine doesn’t start breaking down until approximately 8 hours after it is injected and only then begins to release the drug, Exparel keeps working when the other medications begin to wear off. We continue to inject the other medications as well, which have an immediate effect. This medication protocol is called “bridging” and is one of the reasons we use varied medications with different half lives (the time when half the medicine injected has broken down and no longer is able to prevent pain). Comparable to a chain reaction, when one medication stops, another already is working to quell the pain.

    Since adding Exparel to my multi-modal pain delivery system, it has been a game changer, especially for patients who have had knee replacement surgery. The truth is, for most people knee replacement surgery hurts more than a hip replacement. By adding Exparel and combining it with the other medications and treatments, post-operative total knee replacement patients routinely tell me they essentially have no pain for the first 24 to 48 hours, which is similar to what my total hip replacement patients have been reporting for some time. These results simply are fantastic. I also add Exparel with equally good results to the injections for some total hip replacement patients who have special needs or concerns; however, most total hip replacement patients simply don’t need it.

    By adding Exparel injections to my multi-modal regimen, I’ve also eliminated the need for and associated risks of femoral nerve blocks, with or without pumps and catheters. This has made our pain-management approach simpler, more consistent, and most importantly, safer. When I visit my total knee replacement patients the morning after surgery, they now routinely are moving their knees and eager to begin walking. I no longer have to delay a patient’s first therapy session or request that morning therapy be confined to “in-bed exercise only,” because a femoral nerve block might temporarily have anesthetized the motor component, not just sensory as desired.

    The art for me is anticipating when the Exparel will wear off enough to cause my patients to feel pain and then pre-empting that pain with other medications and modalities.

    Also very encouraging is that both my total and partial knee replacement patients are going home a full day sooner than before because they feel so well. The best therapy in the world is to be back in your own home and as a surgeon I do everything possible to make that happen as quickly as possible.
     
  38. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    • Generally my patients have regional or spinal anesthesia. This is a discussion you will have and a decision you will make with your surgeon and anesthesiologist. There are several advantages to regional anesthesia, including:
      • Patients tend to require fewer drugs for pain.
      • Most report waking up more gradually and with a lot less nausea.
      • Most have no recollection of receiving the anesthetic.
      • Because patients are not intubated during surgery to control breathing, they do not have a sore throat after surgery.
      • Many patients lose less blood when surgery is performed with spinal anesthesia, decreasing the probability of a blood transfusion.

    William A. Leone, M.D., F.A.C.S



    Perioperative Comparative Effectiveness of Anesthetic Technique in Orthopedic Patients by Memtsoudis SG, Sun X, Chiu YL, et al.

    Summary: Controversy continues to surround the impact of anesthetic technique on perioperative outcomes. A recent study of primary joint arthroplasty patients sought to determine whether neuraxial anesthesia favorably influences perioperative outcomes. In this study, patients who underwent primary hip or knee arthroplasty were divided further into groups according to anesthesia technique: general, neuraxial, and combined neuraxial–general. A review of data from almost 400,000 patients found that major morbidity and mortality were significantly lower in those who received neuraxial anesthesia.
     
  39. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    • Joel

      Joel B.

      Anesthesiologist at Physician Anesthesia Services PC

      We are doing TAP blocks with Exparel almost exclusively. While they do provide a dramatic reduction in the narcotic requirement, there are a couple of considerations:
      1. You have to balance density of block with spread of the block. For our blocks, we dilute a 20 cc vial (266 mg, 3% bioavailable at any given time) down to 60 cc (no cup for mixing, just draw it all up in a 60 cc syringe, and then distribute that into 4 15 cc aliquots in 20 cc syringes that are y'd together for increased efficiency. This provides a balance between dermatomal spread for the field block while still maintaining sufficient density to see a difference.
      2. Observed onset time is 30-40 min before appreciable results - therefore it is better to do it before the surgery than after, as well as being easier than working around the bandages post-op.
      3. Observed duration of action for us has been 36-40 hrs. While I have every confidence that there is an observed statistically significant opiate sparing effect for 73 hrs in the study provided by the vendor, in talking with the patient, they can tell you when they felt the block wear off, much like any other block. This has been usually a day and a half to just under two days. They do far better during that time however.
      4. This covers somatic nerves and not visceral nerves. Management of expectations is key in any block, including this one. They should expect a decrease in the sharp incisional pain, but they will still have the dull aching visceral pain and need analgesics, narcotic or otherwise.
      5. This is not an epidural. The disadvantages of epidurals are not present, and one must occasionally remind the surgeon of this, however, it is not as effective an intervention as an epidural in terms of analgesia and must be supplemented with oral or parenteral analgesics to cover unblocked nerves. If you think your patient needs an epidural, do not use this as a substitute.
      6. I have used TAP catheters in another institution during fellowship, and they do provide a denser block that is adjustable to some extent, although that is dependent on the concentration and maximum rate determined by limits of toxicity. That being said, the logistics of placing, in-servicing RNs on multiple floors and rounding on TAP catheters make that an almost impossible answer for our group, while surgeon buy-in was dramatically for Exparel over TAP catheters, primarily for logistics reasons on their end as well. While patient care is paramount, this includes being able to safely care for each patient, and Exparel provided us with a more feasible way of doing that. (No, I am not paid by them)
      7. Exparel, once introduced onto formulary, will work its way into other elements of your block practice, and not all of them for the benefit of the patient or the practice. I have several orthopedic surgeons who now do their total knee replacements with Exparel. They have refused to undertake any head-to-head study of this versus a continuous block. This has materially affected both the patients and our practice. This is a private practice environment, and they view this as a simplification of the postoperative period. They do request that I block their revision TKAs however. Not all of their colleagues have followed suit, but it is a market targeted by the Exparel vendors.
      8. The idea of Local Anesthetic Systemic Toxicity with Exparel is a terrifying one for me, given the duration of action. There are strict guidelines for the use of this drug, and, while you may observe them, realize that some surgeons will be less observant and infinitely less capable of recognizing and dealing with LAST than you are.
      9. Regarding motor block, this does not seem neither to be pronounced nor clinically significant.

    http://www.paspc.com/index.php?page=about-us
     
  40. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    I've diluted the Exparel (266mg/20 mls) to as much as 80 mls. The more one dilutes the drug the shorter the duration. When I dilute the drug to 60-80 mls I add decadron to the mixture (2 mg per 15-20 mls of total volume) which helps to obtain a mean duration of 30- 36 hours of real, effective analgesia post block. I am seeing 36-40 hours of block duration with 266 mg of Exparel diluted to 60 mls ( I add decadron to each syringe).

    The longest duration of analgesia I have seen was using undiluted Exparel for an open Inguinal hernia repair; the block lasted for 48 hours in duration.

    That said, if you want reliable dermatomal spread dilution of the Exparel is needed; Surgical pain relief at the T10 dermatome and below only requires a classical TAP block with 20-30 mls per side. Surgical pain relief above T10 (T7-T10) and below T10 (T10-L1)
    requires at least 30 mls per side (15 mls for the Medial Compartment and 15 mls for the Lateral Compartment). In obese patients I sometimes utilize a total volume of 80 mls (40 mls per side, 20 mls + 20 mls per compartment) but the duration is usually decreased to 24-30 hours.

    The sweet spot for Exparel (266 mg) is the 40-60 ml total Volume range where duration routinely exceeds 36 hours for solid postop pain relief.
     
  41. Noyac

    Noyac ASA Member SDN Advisor 10+ Year Member

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    Blade, dude, seriously, WTF?
     
  42. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    My responses were intended to prove the following:

    Exparel is safe and effective
    Exparel is NOT like Rapacuronium as it does not have a 2-3% incidence of major side-effects/complications
    Exparel doesn't last 72 hours
    Exparel is useful for local injection and sensory/field blocks like TAP or Adductor Canal
    Exparel use will increase dramatically once it gets FDA approval for nerve blocks
     
  43. Mman

    Mman Senior Member 10+ Year Member

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    So, short the stock all you want but be prepared to lose money as the drug is safe and effective.[/QUOTE]

    The stock is so overpriced compared to earnings that I'm not sure the drug being "safe and effective" means anything at all to an investor.
     
  44. Noyac

    Noyac ASA Member SDN Advisor 10+ Year Member

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    Now that's more like it.
     
    epidural man likes this.
  45. BuzzPhreed

    BuzzPhreed

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    Earnest question. Earnest answer.

    No need to block the plexus so high now that we have routine availability of ultrasound. You can pick it off lower but still a little higher than the classic supraclavicular. Since doing it this way I've never had a unilateral phrenic nerve palsy. Never dropped a lung. Never had a Horner's. Never injected into a vessel. Put 23 mL around the plexus and at the end sit the patient up and drop the last 7 mL on the suprascapular grove and you nail the armpit too. Perfect this and you'll never do an interscalene again.
     
  46. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    I've got to call the "never had a phrenic nerve palsy" pure B.S. You have never had a SYMPTOMATIC phrenic nerve palsy but you have blocked the phrenic nerve. With our patient population and volume (very high) we see about 3-4 symptomatic patients with respiratory complications following an ISB. I think that is around 0.5-1.0% incidence. Since you are doing a SCB I would expect your incidence of symptomatic phrenic nerve palsy to be around half of that or 0.25%-0.5%. An incidence that low requires several thousand patients to actually see the complication.
     
  47. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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  48. Noyac

    Noyac ASA Member SDN Advisor 10+ Year Member

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    This is a good approach. But I have partners that do it this way and to date I have personally had to rescue block a couple of these pts in PACU. Not as solid of a block as the ISB. But I'm not knocking it either, it usually gets the job done from what I've seen.
    Btw, I typically do my ISB lower in the interscalenes groove than the classical approach and like you Buzz, I've never had a phrenic n. Palsy either. But I never ask the pts about it so that's how I get around it. ;).
    To be more accurate though, I'd say I can't remember ever having a symptomatic phrenic n palsy that required any intervention.
     
  49. BLADEMDA

    BLADEMDA ASA Member 7+ Year Member

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    If you do an ISB under U/S the key is to avoid C5 and place the local at C6 or C7. In addition, reduce the volume to 15 mls and remember to use the posterior approach only. The anterior approach (which I used for more than 10,000 ISBs) has a much higher incidence of blocking the Phenic nerve due to the location of the nerve near C5 on the anterior side. In addition, we used to use volumes in excess of 20 mls for this block with only the nerve stimulator.

    A reduction in Volume, the use of U/S and a posterior approach with the local injection at or below C6 will reduce the incidence of respiratory compromise requiring CPAP/BIPAP or Mechanical Ventilation.

    Buzz's approach for shoulder surgery is absolutely fine for patients at high risk of respiratory compromise following an ISB but even his approach still has risk for symptomatic phrenic nerve palsy. I suggest a reduction of local anesthetic volume to less than 20 mls even when utilizing the SCB for those patients at high risk of respiratory compromise post block.
     
  50. BuzzPhreed

    BuzzPhreed

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    Doing classic ISB I've had people huffin-n-puffin in the PACU with even the classic elevated hemidiaphragm when I've been concerned enough to get an xray (i.e. make sure there was no pneumo). Never doing it this way. Anatomically you are nowhere near the phrenic nerve.

    The key is to block around the plexus when you see it. Trace up from the supraclavicular grove until you find what looks like a snowman. Then walk the needle all the way around the plexus at that point dropping 5-7 mL in each spot. The probe will be almost at the base of their neck, maybe a little lower. Again save the last 7 mL (or so) and drop that on the suprascapular grove.

    After doing a few dozen of these blocks I haven't had to rescue anyone in the PACU. If you skip the suprascapular part you'll get the occasional patient who will complain of pain in their armpit.
     
  51. BuzzPhreed

    BuzzPhreed

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    No. Wrong.
     

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