Is Gi sedation with Anesthesia coming to an end?

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BLADEMDA

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For those who rely on Propofol IV sedation to make a living my advice is to plan on an alternate form of income in 5-7 years as there is a new drug about to hit the scene: PHAX

Unlike propofol, PHAX causes no pain on injection or emergence delirium. In conclusion, PHAX may have potential to match propofol in performance as a fast-onset, short-acting IV anesthetic but with less cardiovascular depression, airway obstruction, and pain on injection.

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Anesthesia & Analgesia:
Post Author Corrections: July 29, 2015
doi: 10.1213/ANE.0000000000000856
Research Report: PDF Only
A Phase 1c Trial Comparing the Efficacy and Safety of a New Aqueous Formulation of Alphaxalone with Propofol.
Monagle, John MBBS, MSc, FANZCA, FACHSM, FIPP (WIP); Siu, Lyndon MBBS, FANZCA; Worrell, Jodie RN; Goodchild, Colin S. MA, MB, BChir, PhD, FRCA, FANZCA, FFPMANZCA; Serrao, Juliet M. MBBS, PhD, FRCA


BACKGROUND: Phaxan(TM) (PHAX, Chemic Labs, Canton, MA) is an aqueous solution of 10 mg/mL alphaxalone and 13% 7-sulfobutylether [beta]-cyclodextrin (betadex). In preclinical studies, PHAX is a fast onset-offset IV anesthetic like propofol, but causes less cardiovascular depression. This first-in-man study was designed to find the anesthetic dose of PHAX and to compare it with an equivalent dose of propofol for safety, efficacy, and quality of recovery from anesthesia and sedation.

METHODS: The study adhered to compliance with Good Clinical Practices regulations (clinical trials registry number, ACTRN12611000343909). This randomized, double-blind study compared PHAX and propofol using a Bayesian algorithm to determine dose equivalence for effects on the bispectral index (BIS). Male volunteers, ASA physical status I, gave written informed consent (n = 12 per group; PHAX or propofol). Parameters assessed for 80 minutes after drug injection (single bolus dose) were pain on injection, involuntary movement, BIS, blood pressure, need for airway support, and, as measures of recovery from sedation, the Richmond Agitation and Sedation Scale and the Digit Symbol Substitution Test. Arterial blood was withdrawn for biochemistry, hematology, and complement levels.

RESULTS: No subject complained of pain on injection with PHAX, whereas 8 of the 12 subjects given propofol did. Nine PHAX and 8 propofol subjects reached BIS values of <=50: median (interquartile range [IQR]) mg/kg dose = 0.5 (0.5-0.6) for PHAX and 2.9 (2.4-3.0) for propofol. The lowest median BIS reached was 27 to 28 for both agents with no significant differences between them for timing of onset and recovery of BIS. The concomitant median changes in systolic and diastolic blood pressures were -11% vs -19% for systolic and -25% vs -37% for diastolic in PHAX- and propofol-treated subjects, respectively. Nine of the 12 propofol-treated subjects and none of 12 PHAX-treated subjects required airway support. For subjects reaching an equivalent BIS of <=50: a Richmond Agitation and Sedation Scale score of 0 was reached at a median of 5 (IQR, 5-10) and 15 (IQR, 10-20) minutes after PHAX and propofol, respectively; BIS returned to 90 at a mean of 21 (SD, 10.1) and 21 (SD, 9.2) minutes after PHAX and propofol, respectively; and Digit Symbol Substitution Test scores returned to predrug injection values at median of 50 (IQR, 35-72.5) and 42.5 (IQR, 35-76.3) minutes after PHAX and propofol, respectively. There was no increase in C3 and C4 complement fractions after either drug.

CONCLUSIONS: PHAX causes fast-onset, short-duration anesthesia with fast cognitive recovery similar to propofol, but with less cardiovascular depression, or airway obstruction and no pain on injection.
 
Anesth Analg. 2015 May;120(5):1025-31. doi: 10.1213/ANE.0000000000000559.
Alphaxalone Reformulated: A Water-Soluble Intravenous Anesthetic Preparation in Sulfobutyl-Ether-β-Cyclodextrin.
Goodchild CS1, Serrao JM, Kolosov A, Boyd BJ.
Author information

Abstract
BACKGROUND:
Alphaxalone is a neuroactive steroid anesthetic that is poorly water soluble. It was formulated in 1972 as Althesin® using Cremophor® EL, a nonionic surfactant additive. The product was a versatile short-acting IV anesthetic used in clinical practice in many countries from 1972 to 1984. It was withdrawn from clinical practice because of hypersensitivity to Cremophor EL. In the investigations reported here, we compared the properties of 3 anesthetics: a new aqueous solution of alphaxalone dissolved in 7-sulfobutyl-ether-β-cyclodextrin (SBECD, a water-soluble molecule with a lipophilic cavity that enables drug solubilization in water); a Cremophor EL preparation of alphaxalone; and propofol.

METHODS:
Two solutions of alphaxalone (10 mg/mL) were prepared: one using 13% w/v solution of SBECD in 0.9% saline (PHAX) and the other a solution of alphaxalone prepared as described in the literature using 20% Cremophor EL (ALTH). A solution of propofol (10 mg/mL; PROP) in 10% v/v soya bean oil emulsion was used as a comparator anesthetic. Jugular IV catheters were implanted in male Wistar rats (180-220 g) under halothane anesthesia. Separate groups of 10 implanted rats each were given IV injections of PHAX, ALTH, or PROP from 1.2 mg/kg to lethal doses. Doses of each drug that caused anesthesia (loss of righting reflex and response to tail pinch) and lethality in 50% of rats were calculated by probit analysis. The drugs were also compared for effects on arterial blood pressure and heart rate.

RESULTS:
IV PHAX, ALTH, and PROP caused dose-related sedation and anesthesia, with 50% effective dose (ED50) values for loss of righting reflex being 2.8, 3.0, and 4.6 mg/kg, respectively. PROP led to death in 10 of 10 rats at doses >30 mg/kg (50% lethal dose (LD50) = 27.7 mg/kg). A dose of alphaxalone 53 mg/kg as ALTH caused 10 of 10 rats to die (LD50 = 43.6 mg/kg), whereas none died when given the same doses of alphaxalone formulated in SBECD. PHAX caused 20% lethality at the maximal dose tested of 84 mg/kg. PHAX caused less cardiovascular depression than PROP. Control experiments with the 3 drug-free vehicles showed no effects.

CONCLUSIONS:
Alphaxalone caused fast-onset anesthesia at the same dose for both formulations (PHAX and ALTH). The use of SBECD as a drug-solubilizing excipient did not alter the anesthetic effect of alphaxalone, but it did increase the therapeutic index of alphaxalone in PHAX compared with ALTH. PHAX has a higher safety margin than the propofol lipid formulation and also the alphaxalone formulation in Cremophor EL (ALTH).
 
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Drawbridge Pharmaceuticals was founded in 2011 and is a privately-held biotechnology company, headquartered in Melbourne, Australia. The company is developing innovative neuroactive steroid compounds for use in critical care situations. Phaxan™ is the lead compound for use as a fast onset and offset intravenous general anaesthetic and sedative.

www.drawbridgepharmaceuticals.com.au

About Phaxan™

Phaxan™ is a novel water based formulation of the neuroactive steroid, alphaxalone. It has a wide therapeutic index and rapid onset and offset of action. The anaesthetic agent in Phaxan™ has been administered in the past as Althesin® when formulated in a different excipient. It was withdrawn in 1984 because of problems with the formulation. Phaxan™ does not have the problems of the Althesin® formulation and is superior to propofol in preclinical models.

Phaxan™ is a registered trade mark for alphaxalone formulated in sulfobutyl ether beta cyclodextrin being developed by Drawbridge Pharmaceuticals.
 
You're point is well taken. THAT is why anesthesiologist will someday cease to exist. These drugs are getting safer and oh wait, so easy a nurse could give it.

<--*Googles company and will continue to do so until that IPO*
 
That's what everyone said about fos propofol 8 years ago
 
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That's what everyone said about fos propofol 8 years ago


I figure the drug company is going to charge $30 per bottle/vial of PHAX. The current price of Propofol is around $2.40 per bottle (20 mls). So, PHAX needs to have a real indication or cost savings to the user to justify the price.

Deleting the Anesthesiologist or CRNA from the GI procedure justifies the cost of PHAX. This is why PHAX may end up not only replacing Propofol in the Gi suite but the CRNA as well.
 
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That's what everyone said about fos propofol 8 years ago

Fospropofol, once metabolized to propofol, is comparable to propofol lipid emulsion, however, the delayed liberation of propofol results in differences in the timing of the pharmacodynamic actions.7 Only liberated drug and not fospropofol exert a CNS effect. The sedative effects are similar to those of propofol emulsion but not equipotent because inactive fospropofol must be converted to propofol. Hence equivalent doses of fospropofol and propofol emulsion will not have similar effects, infact fospropofol has a delayed onset and decreased clinical effect when compared to propofol for producing moderate sedation required for endoscopy procedures.


http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146164/
 
Curr Pharm Des. 2012;18(38):6241-52.
Fospropofol, a new sedative anesthetic, and its utility in the perioperative period.
Abdelmalak B1, Khanna A, Tetzlaff J.
Author information

Abstract
Fospropofol is an intravenous sedative-anesthetic agent that is FDA-approved for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. As a prodrug of propofol, fospropofol's pharmacologic activity results from its breakdown by alkaline phosphatase and release of propofol, which is the active molecule. It exhibits a longer time to peak clinical effect and a more prolonged action compared to propofol. Thus patients may exhibit smoother hemodynamic and respiratory depression compared to propofol lipid emulsion bolus. Another advantage over propofol is that it does not induce a burning sensation on IV administration. Side effects include perineal paresthesia and itching, respiratory depression, hypoxemia, hypotension, loss of consciousness, and apnea with higher IV boluses. Therefore, current recommendations call for it to be administered only by clinicians trained in general anesthesia, who are thus skilled in advanced airway management. Fospropofol has a unique dosing regimen, with a standard dose for adults 18-65 years of age, and a modified dose (75% of the standard dose) for patients > 65 years of age and for sicker adult patients whose American Society of Anesthesiologists physical status score is ≥ 3. Also, the minimum and maximun IV bolus doses are body-weight adjusted to 60 and 90 kg respectively. Available evidence demonstrates that fospropofol in MAC sedation is successful in patients undergoing esophagogastroscopy, colonoscopy and flexible bronchoscopy. The use of fospropofol is also now being explored in many other perioperative settings. In light of current shortages of many anesthetic drugs, whether forspropofol can take the place of propofol in ICUs and operating rooms remains to be determined.
 
So, for those who missed out on PACIRA/EXPAREL, PHAXAN is the next big blockbuster drug to hit anesthesia. If the company goes public (privately held) my bet is that the stock goes up 300-500% from sales of PHAX.

So you are now projecting the future increase in price in a stock that doesn't have a price? What if it IPO's at a market cap of $100B?

When investing, the question is always "at what price". The worst company around can be a great stock to buy if it's cheap enough. Conversely the fastest growing company in the world can be a horrible stock purchase if it's priced to high.

So how much you like a company or product is not relevant to whether or not the stock is a good buy. The question is what price.
 
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Curr Pharm Des. 2012;18(38):6241-52.
Fospropofol, a new sedative anesthetic, and its utility in the perioperative period.
Abdelmalak B1, Khanna A, Tetzlaff J.
Author information

Abstract
Fospropofol is an intravenous sedative-anesthetic agent that is FDA-approved for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. As a prodrug of propofol, fospropofol's pharmacologic activity results from its breakdown by alkaline phosphatase and release of propofol, which is the active molecule. It exhibits a longer time to peak clinical effect and a more prolonged action compared to propofol. Thus patients may exhibit smoother hemodynamic and respiratory depression compared to propofol lipid emulsion bolus. Another advantage over propofol is that it does not induce a burning sensation on IV administration. Side effects include perineal paresthesia and itching, respiratory depression, hypoxemia, hypotension, loss of consciousness, and apnea with higher IV boluses. Therefore, current recommendations call for it to be administered only by clinicians trained in general anesthesia, who are thus skilled in advanced airway management. Fospropofol has a unique dosing regimen, with a standard dose for adults 18-65 years of age, and a modified dose (75% of the standard dose) for patients > 65 years of age and for sicker adult patients whose American Society of Anesthesiologists physical status score is ≥ 3. Also, the minimum and maximun IV bolus doses are body-weight adjusted to 60 and 90 kg respectively. Available evidence demonstrates that fospropofol in MAC sedation is successful in patients undergoing esophagogastroscopy, colonoscopy and flexible bronchoscopy. The use of fospropofol is also now being explored in many other perioperative settings. In light of current shortages of many anesthetic drugs, whether forspropofol can take the place of propofol in ICUs and operating rooms remains to be determined.


Some good men in that study.... My beloved ccf
 
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Not buying it Blade. It's been several months since anyone used exparel at my place. And that was supposed to be a blockbuster.
 
Male volunteers, ASA physical status I, gave written informed consent (n = 12 per group; PHAX or propofol).

[...]

Nine of the 12 propofol-treated subjects and none of 12 PHAX-treated subjects required airway support.

So they gave this new wonder drug to twelve (12) healthy ASA 1 volunteers, no one's respiratory drive was depressed, and suddenly it's the future of procedural sedation?

Wake me up when they try it in the usual obese ASA 3+ patients that are the norm for procedural sedation.

Maybe it'll turn out to be superior to propofol. Maybe it'll be on our formulary the Tuesday after Sugammadex. Maybe ...
 
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What I am trying to figure is why private insurers pay so much for anesthesia (per unit) and so little for Medicare (per unit).

There has got to be some middle ground.

General surgeons generally get paid 60 cents on the dollar for Medicare compared to private?

But Medicare for anesthesia pays like 33 cents (or less on the dollar) per unit than private.

Why?

And there will come a time when anesthesia Mac/deep sedation won't be needed. That's been the billion dollar cash cow in anesthesia the past 10-15 years.
 
What I am trying to figure is why private insurers pay so much for anesthesia (per unit) and so little for Medicare (per unit).

There has got to be some middle ground.

General surgeons generally get paid 60 cents on the dollar for Medicare compared to private?

But Medicare for anesthesia pays like 33 cents (or less on the dollar) per unit than private.

Why?

And there will come a time when anesthesia Mac/deep sedation won't be needed. That's been the billion dollar cash cow in anesthesia the past 10-15 years.

This is where PHAXAM comes into play. A break-through drug for procedural sedation. Sure, the usual haters and doubters persist on SDN (as expected) but PHAXAM will revolutionize procedural sedation in the USA.

We all knew it was just a matter of time before a good drug (next generation up from propofol) made its way into the GI suite WITHOUT the requirement it be administered by personnel trained in advanced airway management.

Just as Midazolam and Fentanyl can be administered by GI doctors PHAXAM will be approved for their use. Of course, GI docs will need to book their ASA 4 cases with anesthesia but 90% of all patients will be able to be sedated in the office utilizing PHAXAM with an RN administering the drug.
 
Sounds like a great drug. Did the patients still breath after the surgeons placed a scope in their mouths and airways? Does this drug relieve laryngospasm? Will this stuff also protect the patients airway when the surgeon asks for abdominal pressure(which I document). I can do exactly what this drug can do with propofol and a steady state infusion. So until the drugs are filled with nanoprobes with brains I am not losing sleep.
 
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Not buying it Blade. It's been several months since anyone used exparel at my place. And that was supposed to be a blockbuster.
Why did your facility stop using exparel? Just curious since we have held off on using to date.
 
Routine anesthesia care for endoscopy cases never became prevalent on the west coast. I've had many friends and family members undergo the procedure with Iv sedation administered by a nurse. They all had good experiences. Most of them don't remember a thing.

In the 1-2% of cases where we are present, we need to document medical necessity in order to get paid.

Is it faster and slicker with anesthesia? Probably.

Is it necessary? No.
 
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We'll be administering this drug as we do most other anesthetic agents. I am not concerned, though it is good to stay ahead of things.

It's true, I wouldn't want to do JUST Gi/endo anesthesia, but that's with or without this new drug.

The fact is that our services keep expanding into areas such as NORA. The services we provide, including comfort, and safety, are in more demand than ever. These services will be provided by anesthesiologists and CRNA/AA's. What model will depend.

I'm not naive, but I feel that the future of anesthesia is a good one. Do we have challenges? Yes, but the overall demand for anesthesia is increasing. Not decreasing. Do we have other "providers" to worry about? Sort of, but they aren't exactly new to the scene. 1 year into PP, I am very happy I've chosen this gig to earn a living. Will I get rich? Depends on your definition.

Not to derail the thread, but even in a doomsday scenario, I'll still be able to live a very comfortable life. I find the job overall very rewarding. Some days more than others of course, but overall I love what we do.
 
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Not buying it Blade. It's been several months since anyone used exparel at my place. And that was supposed to be a blockbuster.


I'm still using a lot of Exparel with excellent results. Patients are paying huge premiums to their insurance companies these days. An operation costs thousands of dollars to those of us with insurance. So, I believe an extra $285 for better postop pain control is worth it; I firmly believe the duration of postop pain control with Exparel exceeds Bupivacaine with dexamethasone. Again, is the extra 16 hours of postop pain control worth $285? I think it is.
 
I'm still using a lot of Exparel with excellent results. Patients are paying huge premiums to their insurance companies these days. An operation costs thousands of dollars to those of us with insurance. So, I believe an extra $285 for better postop pain control is worth it; I firmly believe the duration of postop pain control with Exparel exceeds Bupivacaine with dexamethasone. Again, is the extra 16 hours of postop pain control worth $285? I think it is.
I don't know if it is cost that has people wavering as much as benefit. Is it really offering tremendous benefit? I know what you think, Blade. I'm just hearing very few that see it your way.
 
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I don't know if it is cost that has people wavering as much as benefit. Is it really offering tremendous benefit? I know what you think, Blade. I'm just hearing very few that see it your way.


Tremendous benefit? I've been involved in cases where the patient was able to avoid an ICU stay due to the use of Exparel vs Bupivacaine. I've seen patients leave the hospital with zero pain and never take a narcotic postop at all.

The ability to get LONG analgesia beyond 24 hours utilizing a single shot technique or injections without catheters is only possible with EXPAREL. PACIRA has informed me that an Anesthesiologist in Texas is using Exparel for ISB/SCB prior to Shoulder replacement surgery and reporting 48+ hours of block duration.

Those who think Exparel is dead are wrong. Exparel may be down right now but it is far from out. More studies are expected in 2016 and Pacira will resubmit for nerve block indication to the FDA in 2016.
 
Why did your facility stop using exparel? Just curious since we have held off on using to date.
People have not been impressed by it.
 
Our hospital did a study with total knees and found decreased narcotic significantly, hospital stay decreased, and a bunch of other stuff I can't recall off top of my head were in favor of Exparel.

I'll try to find the paper (it might still be in publishing stage).
 
I thought detomidine/metdetomidine/dexmetdetomidine were supposed to be the miracle drugs that would revolutionize the industry years ago?
 
Tremendous benefit? I've been involved in cases where the patient was able to avoid an ICU stay due to the use of Exparel vs Bupivacaine. I've seen patients leave the hospital with zero pain and never take a narcotic postop at all.

The ability to get LONG analgesia beyond 24 hours utilizing a single shot technique or injections without catheters is only possible with EXPAREL. PACIRA has informed me that an Anesthesiologist in Texas is using Exparel for ISB/SCB prior to Shoulder replacement surgery and reporting 48+ hours of block duration.

Those who think Exparel is dead are wrong. Exparel may be down right now but it is far from out. More studies are expected in 2016 and Pacira will resubmit for nerve block indication to the FDA in 2016.
1 Drug companies don't talk to me.
2 Whatever you are hearing does not sound very scientific.
3 I would like to meet this mythical anesthesiologist.
 
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I would love to see what exparel could do in an epidural. Now that would be great if you could do a single shot epidural and get 48-72hrs of pain control.
 
I would love to see what exparel could do in an epidural. Now that would be great if you could do a single shot epidural and get 48-72hrs of pain control.
I don't like the idea of a 72 hour sympathectomy (that I can't dial back) requiring a monitored bed very much.
 
I don't like the idea of a 72 hour sympathectomy (that I can't dial back) requiring a monitored bed very much.

I have never done it, but epidural saline has been described as a quick way to reverse an epidural block.
 
Tremendous benefit? I've been involved in cases where the patient was able to avoid an ICU stay due to the use of Exparel vs Bupivacaine.

I've never sent a patient to an ICU that could've been avoided if we had Exparel.
 
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I don't know if it is cost that has people wavering as much as benefit. Is it really offering tremendous benefit? I know what you think, Blade. I'm just hearing very few that see it your way.

It doesn't. If a patient has a joint replacement, they are going to hurt for weeks. Whether they need a percocet on POD #1 or #2 or #3 isn't going to change their satisfaction with the procedure 12 months from now when they think back on it.
 
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As with anything in life. Products are great as long as the "other guy is paying for it".

But reading the drug manufacturer product guidelines for reimbursement. Seems to me is Medicare only considers it part of facility fee.

So you are going to be eating a lot of the costs. Private insurers may pay separately for the drug. But Medicare you will eat the cost exparel. (Read page 4 of PDF)

http://www.exparel.com/pdf/Exparel-Billing-Guide-4-06-15-single-pages.pdf

So blade if u were the owner of outpatient surgery center and employee anesthesiologist or even non owner surgeon is giving exparel all the time. How would you feel about your cost/benefit ratio?

You been happy losing money? So patients are happy for a few more hours of pain free for a few extra hours at the expense of your profit margin.
 
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Exparel is not gonna keep pts out of the ICU in any substantial numbers. That just isn't going to happen. Blade may have an example but I'm sure we could all come up with something in our armamentarium that would achieve the same effect. Exparel ain't it. It's the first 24 hrs that keeps them out of the ICU mostly and any good block can cover this time period. If you need more time, then place and epidural or a peripheral catheter. There is always more than one way to skin that cat.

I call bullcrap on that.
 
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I've never sent a patient to an ICU that could've been avoided if we had Exparel.
Ditto - ICU required for pain control? Huh?
 
Ditto - ICU required for pain control? Huh?


Ever do a triple re-do Ventral Hernia on a morbidly obese patient taking NORCO q 4 hours? Well, I do them fairly routinely and am achieving excellent results with my Exparel/Dexamethasone/Buprenorphine combination:

1. ICU or Step Down unit avoided
2. Pain Scores of 2 or less in PACU
3. Pain Scores of 2 or less at 24 and 36 hours postop
4. Anticoagulation started on POD 1 in the AM

Exparel is a great drug when utilized by the right Anesthesiologist for the right patient. I suspect many on SDN aren't doing their Bilateral TAP blocks as described by Hebbard; in particular, 99% of patients have a TAP plane in their medial quadrants even when the abdominus muscle isn't evident on U/S.

To dismiss the use of Exparel where it can replace an Epidural or block catheter(s) doesn't optimize patient care or satisfaction scores.
 
Liposomal Bupivacaine (Extended-Release Local Anesthetic) Improves Outcomes in Ileostomy Reversal Surgery
Aaron Skolnik, B.S., Christopher Mantyh, M.D., Timothy Miller, M.B., Ch.B., Tong J. Gan, M.D.
Duke University Medical Center, Durham, North Carolina, United States
Background:

The efficacy of liposomal bupivacaine (Exparel®), an extended-release formulation of the local anesthetic bupivacaine, has been demonstrated in patients undergoing bunionectomy and hemorrhoidectomy. The present study evaluates the efficacy of liposomal bupivacaine (LB) in ileostomy reversal surgery.

Methods:

Adults scheduled to undergo ileostomy reversals (n=25) were prospectively treated with liposomal bupivacaine (266 mg) via subcutaneous administration intraoperatively at the surgical site. The primary outcome was total opioid consumption during the first 24 hours postoperatively as well as for the duration of the patient’s hospitalization. Secondary outcomes included: length of hospital stay, maximum pain score (0-10 on the Numerical Rating Scale [NRS]), and whether the patient reported nausea and/or received anti-emetic medication. The data were compared retrospectively with a similar cohort (n=35) who received 10 mL of plain bupivacaine 0.25% for analgesia. Student's t-test and two-proportion z-test were used for statistical analysis. A p-value <0.05 was considered statistically significant.

Results:

Males comprised 68% (17/25) of the LB group and 54% (19/35) of the control group (P=0.2851). The mean ages in the treatment and control groups were 47.9 ± 16.1 and 56.4 ± 13.1 years, respectively (P=0.0349). Patients receiving LB required significantly less rescue opioid medication during the first 24 hours postoperatively versus control (8.4 ± 10.2 vs. 29.1 ± 27.9 mg IV morphine-equivalents, P=0.0002). The total amount of morphine-equivalent doses in the treatment group was also lower for the duration of their hospitalization compared to those in the control group (16.3 ± 21.6 vs. 79.9 ± 146.1 mg IV morphine-equivalents, P=0.0158). Additionally, patients who received LB experienced a significantly shorter mean hospital length of stay (1.3 ± 1.5 vs. 3.2 ± 3.2 days, P=0.0037). The LB group also experienced lower maximum pain scores versus control during both the first 24 hours following surgery (5.1 ± 3.0 vs. 6.9 ± 2.4, P=0.0231) and for the remainder of the hospitalization (4.4 ± 3.4 vs. 7.0 ± 2.7, P=0.0121). There was, however, no significant difference in the percentages of patients who reported nausea (32.0% vs. 42.9%, P=0.3937) or who received anti-emetic medication (36.0% vs. 48.6%, P=0.3325) between the treatment and control groups.

Conclusion:

For patients undergoing ileostomy reversal procedures, liposomal bupivacaine is associated with a decrease in opioid consumption, length of hospital stay, and maximum pain scores.
 
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ANESTHESIOLOGY, HEALTHCARE, LEADERSHIP, MEDICAL EDUCATION, SOCIAL MEDIA
CHANGING CLINICAL PRACTICE SHOULDN’T TAKE SO LONG
JULY 10, 2015 ERMARIANO


An interesting article I read recently confirmed previous studies’ estimation that it takes an average of 17 years before research evidence becomes widely adopted in clinical practice (1)–17 years!

In this article, Morris and colleagues differentiate “translational research” into two types: Type 1 (T1) which refers to experimental testing of basic science research findings in human subjects; and Type 2 (T2) which is the process of taking the results of clinical research and changing clinical practice based on them.




Changing clinical practice shouldn’t take 17 yrs. #leadership #healthcare
CLICK TO TWEET




In 2001, the Institute of Medicine released “Crossing the Quality Chasm: a New Health System for the 21st Century.” One of the ten rules for redesigning the system refers to evidence-based clinical decision-making. The report brief explicitly states: “Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place.”

Changing physicians’ behavior is rarely easy (although occasionally it can be), and many smart people have tried to study what works and what doesn’t. One study published in JAMA that focused on physician adherence to practice guidelines identified 7 categories of change barriers (2):

  1. Lack of awareness (don’t know guidelines exist)
  2. Lack of familiarity (know guidelines exist but don’t know the details)
  3. Lack of agreement (don’t agree with recommendations)
  4. Lack of self-efficacy (don’t think they can do it)
  5. Lack of outcome expectancy (don’t think it will work)
  6. Inertia (don’t want to change)
  7. External barriers (want to change but blocked by system factors)
Outside of medicine, many industries have explored the reasons behind failure of change management or failure of implementationand have made suggestions intended to facilitate change. While these recommendations make sense, they are often easier said than done. In health care, there is a great deal of “dogma-logy” (the non-scientific practice of doing what you’ve been told to do based on no available evidence) that must be overcome. Implementation researchers suggest “incremental, context-sensitive, evidence-based management strategies for change implementation” and the need for local champions within front line staff (e.g., nurses and unit managers) to drive change (3). This is consistent with lean management. This still may not be enough, especially if the proposed change is perceived as being overly complex or just more work (4).

The evolution of modern communication may help overcome some of the perceived barriers (2). Use of social media, Twitter in particular, may be a powerful tool to rapidly disseminate new knowledge. It can be used to share new journal articles as they are published or exciting research results even before they are published. Physicians can follow their professional societies and scientific journals, but also follow thought leaders, business schools, and economic journals that post on organizational culture and change management. In the era of Twitter chats and “live-tweeting” medical conferences, lack of awareness (#1) or familiarity (#2) is no longer an acceptable excuse.

In addition, social media networks may also provide moral support (#4) through global conversations, and colleagues may provide real-life examples of successful implementation strategies (#5) that may help generate enough motivation to drive change (#6). However, sometimes inertia may be easy to overcome. According to Dr. Audrey Shafer, Stanford Professor and physician anesthesiologist,“There should be some acknowledgement of the complexity-to-benefit ratio. If complexity of the change is low, and the benefit high, then I believe the behavioral change is swifter. The prime example in my lifetime is the use of pulse oximetry. It may have been a long time from the concept of pulse oximetry until the first viable commercially available oximeter was available in clinical practice, but after an anesthesiologist used it once, he/she did not want to do another case without one.”

That still leaves lack of agreement (#3) and external barriers (#7). Even if you don’t agree with the scientific evidence, at least be open to observe. I really like the design thinking approach as described byIdeo and others and think it has a place in health care change implementation. You can download the free toolkit for educatorshere. I tweeted Ideo’s figure of the design process with its 5 phases recently and got a great response.
 
I've done plenty of those cases and never have I sent one to the ICU.


Perhaps, your floor nurses are much better than mine. The floor nurses at my hospital can't handle much. FYI, we are finding that patients leave the hospital sooner with an Exparel TAP block (as described by Hebbard) than those who get the usual IV PCA.
 
Perhaps, your floor nurses are much better than mine. The floor nurses at my hospital can't handle much. FYI, we are finding that patients leave the hospital sooner with an Exparel TAP block (as described by Hebbard) than those who get the usual IV PCA.
Perhaps. I don't mean to doubt your approach, I'm just saying that I doubt it made a huge difference in ICU admission rates even in these pts. The roughest time period for these pts is the first 24hrs post-op. If you get them past this period comfortably then they are much less likely to need ICU. I admit that I haven't done TAP blocks. I'm sure they are nice when performed well. It just seems to me that there is a lot of misinformation out there in medicine these days. Some good information as well but weeding thru the crap is hard when you are newer at this game. I see youngsters come in and want to change things up all together while the older guys (me) say things like, that's been tried but was not found to be superior therefore we do things this way. We spend time educating nurses and surgeons and even administration. Things work well when they are well planned out and everyone is onboard.

I would love to come hang out with you for a day or two. It sounds like your practice is quite different from mine.
 
Perhaps. I don't mean to doubt your approach, I'm just saying that I doubt it made a huge difference in ICU admission rates even in these pts. The roughest time period for these pts is the first 24hrs post-op. If you get them past this period comfortably then they are much less likely to need ICU. I admit that I haven't done TAP blocks. I'm sure they are nice when performed well. It just seems to me that there is a lot of misinformation out there in medicine these days. Some good information as well but weeding thru the crap is hard when you are newer at this game. I see youngsters come in and want to change things up all together while the older guys (me) say things like, that's been tried but was not found to be superior therefore we do things this way. We spend time educating nurses and surgeons and even administration. Things work well when they are well planned out and everyone is onboard.

I would love to come hang out with you for a day or two. It sounds like your practice is quite different from mine.


It's tough to get bilateral Tap blocks to last 24 hours with Bupivacaine, Dexamethasone and Buprenorphine. I'm seeing maybe 20-22 hours of analgesia even with the complete cocktail and sometimes it only lasts 16-18 hours in younger patients when I exclude the Buprenorphine. But, with Exparel plus Dexamethasone I'm getting 36+ hours of solid post op analgesia. A good bilteratal TAP with exparel and decadron will always get the patient through the first 1.5-2 days with good analgesia. The key is doing the correct TAP technique and that is something not everyone does well (unfortunately).

TAP blocks are provider dependent more so than almost any other block due to the medial Quadrant issue which most providers simply don't fully grasp. In order to reliably block T7-T9 the Medial Quadrant must be properly injected with the local. This means finding the TAP plane even when there is no obvious TA muscle visible on U/S (trust me there is almost always a remnant fascial plane to inject into) in addition to placing 5-6 mls of local into the Rectus Sheath for very high midline incisions. Both the medial quadrant and rectus sheath blocks can be performed utilizing the same skin puncture.

FYI, I've been at this gig for over 2 decades now so I'm no novice when it comes to seeing what works and what doesn't. The TAP when performed properly with Exparel is a nice way to provide postop analgesia for just about any open or laparoscopic abdominal/inguinal surgery.
 
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I perform my Rectus Sheath blocks in the same location as the Medial Quadrant blocks. This way I don't need to do another skin puncture. The high Rectus sheath blocks adds to the analgesia for midline incisions. I utilize 4-5 mls for my Rectus Sheath followed by 10 mls for the Medial Quadrant block. I utilize another 15 mls of local for the lateral quadrant. Hence, about 30 mls of local per side for a total volume of 60 mls per patient.

If the procedure does not involve any dermatomes above the umbilicus I can exclude the Rectus/Medial Quadrants and if the procedure does not involve any dermatomes at the umbilicus or below I exclude the lower/lateral quadrant blocks.
 
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