Femoral nerve block and quadriceps weakness

This forum made possible through the generous support of SDN members, donors, and sponsors. Thank you.
reanimatore said:
Thanks for that.

On a separate note, the clinician polls in this article are interesting. I'm surprised so many people use an interscalene block as their approach of choice for hand/wrist surgery.
Click to expand...

Infraclavicular is the Bomb. Best of all the Brachial Plexus Blocks for surgery at the elbow and below. (IMHO of course)
 
Mman said:
They better not be as I'm pretty sure that violates federal law.
Click to expand...

The sales reps, Local and Regional, are promoting it like beer at a hockey game.

I must say this stuff for an Adductor Canal is the future my friends. Solid post op pain relief for 3 days with no motor block. The only negative is the cost.

That said, this stuff works and there is no issue with catheter dislodgement.
 
However, to ensure the appropriate
spread throughout the adductor canal we believe
that intermittent boluses are preferable to continuous
infusions. Studies have shown that intermittent
boluses provide superior analgesia compared with
continuous infusions via an epidural catheter.30
Although the mechanism is unknown, this phenomenon
might also be present with peripheral nerve
blockades. Whether the ACB should be performed
as a catheter technique (repeated boluses or continuous
infusion) or by a single-shot technique should
be subject to further investigation.
 
The difference in pain level from the morning of POD1
diminished and did not differ significantly between the groups
for the rest of the investigation period. This might be attributed to
displacement of the saphenous nerve catheter during ambulation
and physiotherapy. A subgroup ultrasound control scanning of
the spread of the injectate, seen during the last bolus just before
catheter removal on POD2, revealed that 5 of 8 catheters were
displaced to a location outside the adductor canal. The control
scanning of the subgroup was randomly chosen. No catheters
were completely withdrawn. Displacement of the catheters during
knee movements could be one of the main limiting factors
for their use in the adductor canal. An earlier removal of the
catheter or a better way to secure it could be a solution.We found
no indication in this study to keep the catheter for longer than
the morning of POD1. This is in agreement with the study
of Ilfeld et al.25
 
Last edited:
At least I read up on everything that I do. Exparel is superior to Adductor canal catheters because there is no chance of catheter dislodgement.

At this time, best available evidence suggests to me that a single shot ACB with 0.5% Bup and 8 mg of decadron, which will last over 30 hours, is just as good, if not better, than placing a catheter in the Adductor canal.

Give it a try Slim. Skip the catheter and go with the Bup and PF decadron or go First Class with Exparel. I fully understand if your patient population prohibits the use of Exparel due to cost ($280) as the Bup with Decadron runs $3.00 total.

$3.00 VS. $280.00
 
BLADEMDA said:
At least I read up on everything that I do. Exparel is superior to Adductor canal catheters because there is no chance of catheter dislodgement.

At this time, best available evidence suggests to me that a single shot ACB with 0.5% Bup and 8 mg of decadron, which will last over 30 hours, is just as good, if not better, than placing a catheter in the Adductor canal.

Give it a try Slim. Skip the catheter and go with the Bup and PF decadron or go First Class with Exparel. I fully understand if your patient population prohibits the use of Exparel due to cost ($280) as the Bup with Decadron runs $3.00 total.

$3.00 VS. $280.00
Click to expand...

But, for the CEO and his friends a First Class Adductor Canal block with Exparel means 72hours of major pain relief
 
That's exactly what I've been doing. 15ccs of.75% ropivicaine 1 hr. before PT and another smaller bolus before bed. No continuous infusion.

2 amps of mastisol and 2 criss crossed tegaderms with the catheter wound up underneath them + appropriately taped catheter cap (taped to the catheter itself).
Solid catheter w/o dislodgement. Comes out with the final bolus the night of POD #2.

Explera sounds very promising. I think the fact that its a liposomal preparation makes it less toxic. I'm not sure though. Good discussion.
 
sevoflurane said:
That's exactly what I've been doing. 15ccs of.75% ropivicaine 1 hr. before PT and another smaller bolus before bed. No continuous infusion.

2 amps of mastisol and 2 criss crossed tegaderms with the catheter wound up underneath them + appropriately taped catheter cap (taped to the catheter itself).
Solid catheter w/o dislodgement. Comes out with the final bolus the night of POD #2.

Explera sounds very promising. I think the fact that its a liposomal preparation makes it less toxic. I'm not sure though. Good discussion.
Click to expand...

Looks solid. But again, there is no evidence that your "technique" is superior to my single shot ACB which lasts for 30 hours and costs $3.00.

Ditto for my Exparel ($280) vs. your catheter technique ($70).
 
BLADEMDA said:
The sales reps, Local and Regional, are promoting it like beer at a hockey game.

I must say this stuff for an Adductor Canal is the future my friends. Solid post op pain relief for 3 days with no motor block. The only negative is the cost.

That said, this stuff works and there is no issue with catheter dislodgement.
Click to expand...



Hmm, I was researching it and apparently back in December a federal appeals court overturned the conviction of a drug rep who was touting the virtues of an off label use of a drug. Apparently it only applies to the 2nd Circuit (NY, CT, VT) but they thought it might end up heading to the Supreme Court.

Would be interesting since it's a long enforced federal regulation that drug reps can't promote off label use.

Either you practice in the 2nd Circuit or drug companies are getting really ballsy these days.

http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off-label-marketing.html?_r=0
 
BLADEMDA said:
Looks solid. But again, there is no evidence that your "technique" is superior to my single shot ACB which lasts for 30 hours and costs $3.00.

Ditto for my Exparel ($280) vs. your catheter technique ($70).
Click to expand...


I assume you are quoting the hospital cost to acquire, what's the actual amount billed to the patient for each out of curiousity?
 
Mman said:
I assume you are quoting the hospital cost to acquire, what's the actual amount billed to the patient for each out of curiousity?
Click to expand...

No idea. But, I wouldn't use Exparel on any patient without insurance. Instead, those who aren't insured get a single shot block which is Equal in terms of outcome.

I do not own stock in the company and really don't care if you use it. But, it does have its advantages.
 
BLADEMDA said:
No idea. But, I wouldn't use Exparel on any patient without insurance. Instead, those who aren't insured get a single shot block which is Equal in terms of outcome.

I do not own stock in the company and really don't care if you use it. But, it does have its advantages.
Click to expand...

I have no desire to use it until it gets approved for use on peripheral nerve blocks. Liability is way too high until then IMHO.
 
Mman said:
I have no desire to use it until it gets approved for use on peripheral nerve blocks. Liability is way too high until then IMHO.
Click to expand...

When it get approves next year by the FDA for sensory blocks I should have performed several hundred blocks with it.

For the adductor Canal block with a catheter all you need to do is bolus the catheter once with a solution of 0.5% Bup with decadron (20 mls) on POD1 in the late AM to get another solid 24 hours of pain relief.
 
Mman said:
I have no desire to use it until it gets approved for use on peripheral nerve blocks. Liability is way too high until then IMHO.
Click to expand...

Someone who isn't using PF decadron with local for their blocks is HIGHLY unlikely to use Exparel for a sensory nerve block.

As for me, I am well aware of the medical liability but Exparel is perfectly safe when used for sensory blocks or local infiltration. Motor blocks (ISB, Femoral, etc) is a different story and I won't be using it in that manner until it gets FDA approval.
 
DepoFoam-encapsulated bupivacaine is a new formulation of bupivacaine that provides slow sustained release of bupivacaine from multivesicular liposomes. Compared to placebo, it has been shown to produce prolonged analgesia with an opioid sparing effect, although more adequately powered trials are needed to assess its efficacy and duration of analgesia compared to standard local anesthetic solutions. At present, it is approved by the FDA for use via local infiltration after bunionectomy and hemorrhoidectomy. It has not been shown to be more toxic compared to plain bupivacaine, and it does not have markedly different cardiac effects than plain bupivacaine. It appears safe for use in patients with moderate hepatic impairment and does not warrant dose adjustment in that group.25 It has not been evaluated for use via intrathecal, epidural, or perineural administration or in pediatric and pregnant patients.43 More multicenter trials are needed to evaluate its efficacy and safety in these populations. If its safety and efficacy are established for epidural, intrathecal, and perineural use, it holds a potentially valuable place in the analgesic arsenal for use against postoperative pain and may substantially reduce the cost and complications associated with catheter and local anesthetic infusion pumps. In addition, the opioid sparing effects of MVL bupivacaine are valuable in potentially reducing opioid-related side effects. This in turn may reduce unwanted hospital admissions related to postoperative pain or opioid side effects.
 
PARSIPPANY, N.J.--(BUSINESS WIRE)-- Pacira Pharmaceuticals, Inc. (NAS: PCRX) today announced findings from two new studies supporting the use of EXPAREL® (bupivacaine liposome injectable suspension) infiltrated into the transversus abdominis plane for postsurgical pain management. Infiltration into the transversus abdominis plane (or iTAP) is being increasingly utilized for postsurgical analgesia during upper or lower abdominal procedures for up to 72 hours of postsurgical analgesia with a non-opioid, local anesthetic.

The first study, presented at the 2013 Annual Meeting of the International Anesthesia Research Society (IARS) in San Diego on Sunday, May 5,2013 evaluated the use of EXPAREL administered via iTAP for postsurgical pain control in 13 patients who underwent open abdominal hernia repair. A team of researchers led by Dennis E. Feierman, M.D., vice chairman in the Division of Anesthesiology at the Maimonides Medical Center in Brooklyn, N.Y. recorded pain scores and patient satisfaction following EXPAREL administration via iTAP. This study was supported by Pacira Pharmaceuticals, Inc.

Key findings include:
•Patients' pain was well-controlled through 72 hours (mean pain score was <3 out of 10 through 120 hours after surgery, where 10 represents the worst possible pain)
•Most patients reported being "satisfied" or "extremely satisfied" with pain control at discharge and postsurgical day 10 (mean score of 4.4 at discharge and 4.6 at postsurgical follow-up visit on a scale of 0-5, where 5 represents the highest possible satisfaction)
•No serious adverse events were reported in the study

"The consistent results we observed from this study support the safety and clinical value of EXPAREL. The prolonged pain relief and improved patient satisfaction we observed using EXPAREL in TAP infiltration after large and generally painful umbilical hernia repairs was unprecedented," said Mark Kronenfeld, M.D., Vice Chairman of Anesthesiology and Medical Director of Perioperative Services at Maimonides Medical Center in Brooklyn, N.Y. and co- principal investigator on this research. "We are excited by the results, which support our Medical Center's goal of an opioid-sparing postoperative patient experience to avoid the often adverse side effects associated with the use of opioids."

The second study, a retrospective review of 20 patients undergoing hand-assisted nephrectomies and colorectal procedures and receiving an iTAP with EXPAREL for postsurgical pain control, was discussed during a poster presentation held on Saturday, May 4, 2013 at the 38th annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) in Boston.

Key findings include:
•Patients experienced minimal pain through 72 hours (mean pain score at rest of 2.3 or lower through 72 hours)
•Patients reported numbness at their incision site lasting between 48 to 72 hours postsurgically
•There were no treatment-related adverse events in the study

"Infiltration into the transversus abdominis plane using traditional local anesthetics is a highly-effective technique to produce regional pain control during surgery, but the postsurgical benefits rarely extend beyond 18 hours," said Jacob Hutchins, M.D., the study's lead investigator and Director of Perioperative and Interventional Pain Service in the Department of Anesthesiology at the University of Minnesota. "Based on this retrospective review, we're pleased to report that using EXPAREL in a TAP infiltration was shown to be a safe and effective option to extend postsurgical pain control for up to three days, when postsurgical pain is at its worst."

EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. Since EXPAREL is used in a peri- or postsurgical setting in the same fashion as current local anesthetics, it has broad applications across a wide variety of surgical specialties ranging from general and colorectal surgery to bariatric and plastic surgery procedures.
 
BLADEMDA said:
Someone who isn't using PF decadron with local for their blocks is HIGHLY unlikely to use Exparel for a sensory nerve block.

As for me, I am well aware of the medical liability but Exparel is perfectly safe when used for sensory blocks or local infiltration. Motor blocks (ISB, Femoral, etc) is a different story and I won't be using it in that manner until it gets FDA approval.
Click to expand...

My hospital doesn't have PF decadron and there is a massive nationwide shortage so even I pushed them for it, we couldn't get it.


As for Exparel, it can be as perfectly safe as you want. I'm still curious about the cardiac toxicity since it's basically bupivicaine in a liposomal depot. For all we know it's 100x more difficult to resuscitate from a cardiac arrest, the data on that isn't there. I just know FDA approval isn't the linear progression that drug reps would lead you to believe. I'm still dying to get Sugammadex approved for use since it's safer than the drug it would lead to a drastic reduction of use in (succinylcholine). But alas, it's still a work in progress more than 5 years after we should've had it.
 
BLADEMDA said:
PARSIPPANY, N.J.--(BUSINESS WIRE)-- Pacira Pharmaceuticals, Inc. (NAS: PCRX) today announced findings from two new studies supporting the use of EXPAREL® (bupivacaine liposome injectable suspension) infiltrated into the transversus abdominis plane for postsurgical pain management. Infiltration into the transversus abdominis plane (or iTAP) is being increasingly utilized for postsurgical analgesia during upper or lower abdominal procedures for up to 72 hours of postsurgical analgesia with a non-opioid, local anesthetic.

The first study, presented at the 2013 Annual Meeting of the International Anesthesia Research Society (IARS) in San Diego on Sunday, May 5,2013 evaluated the use of EXPAREL administered via iTAP for postsurgical pain control in 13 patients who underwent open abdominal hernia repair. A team of researchers led by Dennis E. Feierman, M.D., vice chairman in the Division of Anesthesiology at the Maimonides Medical Center in Brooklyn, N.Y. recorded pain scores and patient satisfaction following EXPAREL administration via iTAP. This study was supported by Pacira Pharmaceuticals, Inc.

Key findings include:
•Patients' pain was well-controlled through 72 hours (mean pain score was <3 out of 10 through 120 hours after surgery, where 10 represents the worst possible pain)
•Most patients reported being "satisfied" or "extremely satisfied" with pain control at discharge and postsurgical day 10 (mean score of 4.4 at discharge and 4.6 at postsurgical follow-up visit on a scale of 0-5, where 5 represents the highest possible satisfaction)
•No serious adverse events were reported in the study

"The consistent results we observed from this study support the safety and clinical value of EXPAREL. The prolonged pain relief and improved patient satisfaction we observed using EXPAREL in TAP infiltration after large and generally painful umbilical hernia repairs was unprecedented," said Mark Kronenfeld, M.D., Vice Chairman of Anesthesiology and Medical Director of Perioperative Services at Maimonides Medical Center in Brooklyn, N.Y. and co- principal investigator on this research. "We are excited by the results, which support our Medical Center's goal of an opioid-sparing postoperative patient experience to avoid the often adverse side effects associated with the use of opioids."

The second study, a retrospective review of 20 patients undergoing hand-assisted nephrectomies and colorectal procedures and receiving an iTAP with EXPAREL for postsurgical pain control, was discussed during a poster presentation held on Saturday, May 4, 2013 at the 38th annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) in Boston.

Key findings include:
•Patients experienced minimal pain through 72 hours (mean pain score at rest of 2.3 or lower through 72 hours)
•Patients reported numbness at their incision site lasting between 48 to 72 hours postsurgically
•There were no treatment-related adverse events in the study

"Infiltration into the transversus abdominis plane using traditional local anesthetics is a highly-effective technique to produce regional pain control during surgery, but the postsurgical benefits rarely extend beyond 18 hours," said Jacob Hutchins, M.D., the study's lead investigator and Director of Perioperative and Interventional Pain Service in the Department of Anesthesiology at the University of Minnesota. "Based on this retrospective review, we're pleased to report that using EXPAREL in a TAP infiltration was shown to be a safe and effective option to extend postsurgical pain control for up to three days, when postsurgical pain is at its worst."

EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. Since EXPAREL is used in a peri- or postsurgical setting in the same fashion as current local anesthetics, it has broad applications across a wide variety of surgical specialties ranging from general and colorectal surgery to bariatric and plastic surgery procedures.
Click to expand...


Please don't cite one study of 13 patients and a retrospective review of 20 patients as evidence of anything. If you want to make a scientific argument supported by data, do so with relevant sized and designed studies. I am sure they will be coming soon enough. Until then using crappy evidence to support something just makes you look sloppy.
 
Mman said:
Please don't cite one study of 13 patients and a retrospective review of 20 patients as evidence of anything. If you want to make a scientific argument supported by data, do so with relevant sized and designed studies. I am sure they will be coming soon enough. Until then using crappy evidence to support something just makes you look sloppy.
Click to expand...

As I have stated there is a multi site TAP trial using Exparel underway. As of today several thousand patients have received Exparel for Sensory nerve blocks and that number grows daily. On a personal level I plan on using Exparel more frequently.

Since the drug reps are promoting Exparel for TAP blocks (a sensory block) the company, Pacira, already has legal liability if Exparel turns out to be harmful. But, Pacira knows the drug is safe and effective so the Reps are pushing its use in that direction. The same reps are NOT recommending the use of Exparel for any motor blocks.
 
Mman said:
I assume you are quoting the hospital cost to acquire, what's the actual amount billed to the patient for each out of curiousity?
Click to expand...

What about the cost of managing the Adductor canal catheter and the additional charge to the patient for your time on the floor bolusing it?

When you factor in all the costs involved the Exparel looks good especially if you can treat 2 patients with just one bottle (which you can do).
 
BLADEMDA said:
What about the cost of managing the Adductor canal catheter and the additional charge to the patient for your time on the floor bolusing it?

When you factor in all the costs involved the Exparel looks good especially if you can treat 2 patients with just one bottle (which you can do).
Click to expand...

Blade, your recent citations include press releases, statements by pharmaceutical reps, and personal experience. C'mon, man. I understand you are excited about this liposomal bupiv but to act like there is evidence or adequate safety data is just pathetic.
 
fakin' the funk said:
Blade, your recent citations include press releases, statements by pharmaceutical reps, and personal experience. C'mon, man. I understand you are excited about this liposomal bupiv but to act like there is evidence or adequate safety data is just pathetic.
Click to expand...

Disagree. What exactly is "dangerous" about an old drug repackaged in a new way? How and why does a slow release Bupivacaine scare you so much that you need 10,000 patients in a double blind randomized trial to prove safety?

Why is it safe to inject a bottle of Exparel in someone's anus or subcutaneously but "dangerous" to inject the same drug around a sensory nerve?

I'll continue to use Exparel for sensory nerve blocks, local injection in the field and of course, for injections around the anus.😀

I don't own stock in Pacira and agree there is a lot of hype going on with Exparel. But, the drug is safe for local injection and sensory blocks.

Again, I have the option of using or not using Exparel to help my patients. I'm choosing to use it. Others will wait until People like me have performed thousands of blocks with it and even then won't be fully convinced. This discussion reminds me of when Ropivacaine came out years ago. It took me 7 years to convince one partner it was safe and effective. But, he finally came around as will you with Exparel.
 
Mman said:
My hospital doesn't have PF decadron and there is a massive nationwide shortage so even I pushed them for it, we couldn't get it.


As for Exparel, it can be as perfectly safe as you want. I'm still curious about the cardiac toxicity since it's basically bupivicaine in a liposomal depot. For all we know it's 100x more difficult to resuscitate from a cardiac arrest, the data on that isn't there. I just know FDA approval isn't the linear progression that drug reps would lead you to believe. I'm still dying to get Sugammadex approved for use since it's safer than the drug it would lead to a drastic reduction of use in (succinylcholine). But alas, it's still a work in progress more than 5 years after we should've had it.
Click to expand...

Toxicity of Bupivacaine Encapsulated into Liposomes and Injected Intravenously

Comparison with Plain Solutions

Jean Boogaerts, MD,
Anne Declercq, CRNA,
Noelle Lafont, MD,
Hassan Benameur, Eng,
El Mustafa Akodad, Eng,
Jean-Claude Dupont, MD* and
Franz J. Legros, PhD

+ Author Affiliations

Laboratory of Physiopathology, Free University of Brussels, Campus Erasme, Brussels, Belgium, and Cardiac Department, Clinique Reine Fabiola, Montignies-sur-Sambre, Belgium


*Cardiac Department, Clinique Reine Fabiola, Montignies-sur-Sambre, Belgium



Abstract

The acute central nervous system and cardiac toxicities of 0.25% bupivacaine, without adrenalin, encapsulated in multilamellar liposomes were compared with 0.25% plain with and without adrenalin after intravenous infusion at a rate of 0.15 mg·kg&#8722;1·min&#8722;1 with an increase of 0.035 mg·kg&#8722;1·min&#8722;1 every 10 min. Three groups of six anesthetized, unventilated rabbits were studied, The doses of bupivacaine (in mg·kg&#8722;1) which produced seizureular tachycardia, and asystole were determined. The doses of bupivacaine inducing seizure and ventricular tachycardia were significantly higher for liposomal bupivacaine than for the two plain solutions. A statistical comparison of the cumulative lethal doses of bupivacaine 0.25% with adrenalin and of liposomal bupivacaine led to a p = 0.06. Adrenalin did not modify the systemic toxicity of the local anesthetic. This study showed a reduction of nervous and cardiac toxicity of bupivacaine encapsulated in multilamellar liposomes when infused intravascularly
 
Prolonged Analgesia With Liposomal Bupivacaine in a Mouse Model
Grant, Gilbert J. M.D.; Vermeulen, Kristien M.D.; Langerman, Lev M.D.; Zakowski, Mark M.D.; Turndorf, Herman M.D.

Collapse BoxAbstract
Background and Objectives. Currently available local anesthetics have relatively limited duration of action and some may cause severe systemic toxicity. An ultralong lasting local anesthetic would be useful to produce prolonged intraoperative anesthesia and extended postoperative analgesia. The goal of this study was to synthesize a sustained release local anesthetic formulation that would produce prolonged sensory block and decrease the possibility of systemic toxicity.

Methods. The effect of liposomes containing 1.1% bupivacaine on duration of sensory block of the mouse tail was compared with equivalent concentrations of bupivacaine with and without epinephrine. Analgesia was assessed using the tail flick test. Systemic toxicity (LD50) was assessed after intraperitoneal injection and in vitro release rates were compared by dialysis technique for liposomal and plain bupivacaine.

Results. Sensory block was significantly prolonged with liposomal bupivacaine (130 +/- 38 minutes) compared to plain bupivacaine (46 +/- 11 minutes, P < .01) or bupivacaine with epinephrine (81 +/- 28 minutes, P < .05). The LD50 was significantly lower for plain bupivacaine (61 mg/kg, 95% confidence intervals 47-79) than for liposomal bupivacaine (291 mg/kg, 95% confidence intervals 201-422). The time to 50% in vitro release through a dialysis membrane for liposomal bupivacaine (28 +/- 9 minutes) was markedly prolonged compared to plain bupivacaine (7 +/- 1 minutes).

Conclusions. This study shows that liposomal encapsulation of bupivacaine significantly prolongs duration of action and greatly decreases systemic toxicity of the drug. These findings may be promising for the future production of formulations of ultralong lasting local anesthetics with enhanced efficacy and safety.
 
The formulation of Exparel allows for a longer duration of action and a slower absorption into systemic circulation, avoiding high plasma concentrations. Local infiltration can result in significant liposomal bupivacaine systemic plasma concentrations for up to 96 hours; however, significant levels are not correlated with local efficacy. The peak plasma concentration (Cmax) of liposomal bupivacaine occurs at 2 hours for a bunionectomy and 30 minutes for a hemorrhoidectomy. After bupivacaine has been released from Exparel and is absorbed systemically, distribution is expected to be the same as for any bupivacaine HCl. The mean elimination half-life of local administration of 106 mg for a bunionectomy is approximately 34 hours and approximately 24 hours for a 266-mg single dose for a hemorrhoidectomy - See more at: http://www.pharmacytimes.com/public...omal-Bupivacaine-Exparel#sthash.V1uTZJ6q.dpuf
 
Clin J Pain. 2013 Feb 26. [Epub ahead of print]

The Safety of Liposome Bupivacaine, A Novel Local Analgesic Formulation.

Viscusi ER, Sinatra R, Onel E, Ramamoorthy SL.


Source

*Department of Anesthesiology, Thomas Jefferson University, Philadelphia, PA †Department of Anesthesiology, Yale School of Medicine, New Haven, CT ‡Pacira Pharmaceuticals, Inc., Parsippany, NJ §Rebecca and John Moores Cancer Center, La Jolla, CA.


Abstract


OBJECTIVE:: Pooled safety data from 10 randomized, double-blind studies of liposome bupivacaine, a novel local analgesic formulation, were examined. METHODS:: Eight hundred twenty-three patients received liposome bupivacaine (dose, 66 to 532 mg) given locally at the surgical site in 5 different settings (hemorrhoidectomy, bunionectomy, breast augmentation, total knee arthroplasty, and hernia repair); 446 received bupivacaine HCl (dose, 75 to 200 mg) and 190 received placebo. Adverse events (AEs) were monitored for up to 36 days after administration. RESULTS:: Overall, 48% of patients were men and 21% were 65 years and older. Incidence of AEs was 62% for patients receiving liposome bupivacaine, versus 75% and 43% for patients receiving bupivacaine HCl and placebo, respectively. The most common AEs (incidence >10%) in the liposome bupivacaine arms were nausea, constipation, and vomiting. One death was reported in the liposome bupivacaine group and 1 in the bupivacaine HCl group; both deemed unrelated to study drug. Serious AEs were reported in 2.7% of patients receiving liposome bupivacaine, versus 5.4% and 1.1% of those receiving bupivacaine HCl and placebo, respectively. In both the liposome bupivacaine and bupivacaine HCl groups, 6% of patients experienced a cardiac AE; these were primarily tachycardia (4% vs. 5%, respectively) and bradycardia (2% vs. 1%, respectively). Overall incidence of treatment-related cardiac AEs was <1%; all were associated with liposome bupivacaine. All of these events were assessed by investigators as possibly related to study drug; all were mild or moderate in severity, and none required therapeutic intervention. DISCUSSION:: Liposome bupivacaine exhibited acceptable tolerability across 823 patient exposures
 
Hospitals usually have a pharmacy and therapeutics committee that should approve any drug we use for an off label or experimental indication.
This committee usually requires data, at least one valid study to consider the use of the drug.
I am curious how you got the committee to allow you to use Exaprel for nerve blocks despite the absolute lack of evidence?
Maybe you told them it's infiltration?
But even if you did... the only data available right now is on bunions and hemorrhoids!
If you have a bad outcome right now you will be on your own.
 
Planktonmd said:
Hospitals usually have a pharmacy and therapeutics committee that should approve any drug we use for an off label or experimental indication.
This committee usually requires data, at least one valid study to consider the use of the drug.
I am curious how you got the committee to allow you to use Exaprel for nerve blocks despite the absolute lack of evidence?
Maybe you told them it's infiltration?
But even if you did... the only data available right now is on bunions and hemorrhoids!
If you have a bad outcome right now you will be on your own.
Click to expand...

Something like half of all the drugs that are used in pediatrics are "off label"
Disagree with your statement that this is an area for a P & T committee to weigh in on.
"Experimental" is another matter. If there is peer reviewed literature demonstrating a safe and effective use of a drug for an off label indication, that is an indvidual doc's choice that is within the range of professional discretion. I would certainly hope that before a private practice doc uses a new drug for "off label" that there be more than one study validating its use or that if only one it be a very strong one accompanied with an editorial endorsing the technique by a respected journal.
 
Ipassgas said:
At one of our hospitals, our ortho guys told us to stop doing FNB due to weakness before I started. They infiltrate Exparel and love it. I can't get them interested in adductor canal blocks. 🙁
Click to expand...

That's what the joints guys do at our hospital..no more FNB, no more PCA, straight up Exparel in the joint. Patients passing therapy on day 1 (some even on day 0) and going home on POD 1.
 
dr doze said:
Something like half of all the drugs that are used in pediatrics are "off label"
Disagree with your statement that this is an area for a P & T committee to weigh in on.
"Experimental" is another matter. If there is peer reviewed literature demonstrating a safe and effective use of a drug for an off label indication, that is an indvidual doc's choice that is within the range of professional discretion. I would certainly hope that before a private practice doc uses a new drug for "off label" that there be more than one study validating its use or that if only one it be a very strong one accompanied with an editorial endorsing the technique by a respected journal.
Click to expand...

The company, Pacira, is promoting the use of Exparel for TAP and intraarticular injection into the knee.

There is good data showing safety of this local for TAP blocks. But, whether this data is enough to convince you to use it is a matter of personal choice. I don't consider my TAP blocks wth Exparel experimental in any manner and those who do are ignorant of its use around country.

Several large groups around me are using Exparel for sensory blocks. The company has verified this to me and confirmed that the number of TAP blocks just in my immediate area is well over 1,000.
 
ChiDO said:
That's what the joints guys do at our hospital..no more FNB, no more PCA, straight up Exparel in the joint. Patients passing therapy on day 1 (some even on day 0) and going home on POD 1.
Click to expand...

Exparel in the joint is great. I'd take 80 mg from their bottle and do an adductor canal block as well. The Ortho guys can use the rest.
 
BLADEMDA said:
The company, Pacira, is promoting the use of Exparel for TAP and intraarticular injection into the knee.

There is good data showing safety of this local for TAP blocks. But, whether this data is enough to convince you to use it is a matter of personal choice. I don't consider my TAP blocks wth Exparel experimental in any manner and those who do are ignorant of its use around country.

Several large groups around me are using Exparel for sensory blocks. The company has verified this to me and confirmed that the number of TAP blocks just in my immediate area is well over 1,000.
Click to expand...

I agree with you about TAP blocks. Wouldn't agree about a brachial plexus block, or femoral or sciatic block though.
 
BLADEMDA said:
When you factor in all the costs involved the Exparel looks good especially if you can treat 2 patients with just one bottle (which you can do).
Click to expand...

It is against our hospital policy to dispense drugs to multiple patients from a single vial when each patient is charged individually for the entire vial. It's also questionable legally depending on who you ask. So a "multi-dose vial" can be utilized in various situations, but how you bill the patient is relevant in regards to it.

For things like local anesthetics with regional anesthesia, the patient gets billed for the entire vial.

(I'm also not going to a floor to bolus any catheters, we have pumps that can provide infusions and boluses as needed)
 
Mman said:
It is against our hospital policy to dispense drugs to multiple patients from a single vial when each patient is charged individually for the entire vial. It's also questionable legally depending on who you ask. So a "multi-dose vial" can be utilized in various situations, but how you bill the patient is relevant in regards to it.

For things like local anesthetics with regional anesthesia, the patient gets billed for the entire vial.

(I'm also not going to a floor to bolus any catheters, we have pumps that can provide infusions and boluses as needed)
Click to expand...

Slim,

Medicare doesn't reimburse for Exparel if the patient is going to stay in the hospital. Exparel must be used for outpatients. So, ObamaCare isn't paying us a dime for the medication whether I use it on one patient or 3 patients. I never split the vial if there is actually going to be a charge which results in actual payment.

Secondly, Pharmacy can draw up my required dosage under the hood in a "sterile" manner. For example, 3 syringes filled with Exparel (1/3 the bottle for each) which must be used within 4 hours.

Where is the issue here? Free is Free no matter how many times you split the vial.
 
Did my first adductor canal block for arthroscopic ACL repair.

DId USG with 15 mL of Bupiv 0.5% with 4 mg decadron. Above and below ther artery as well as around saphenous nerve. Mid thigh. I ensured tourniquet was above needle entry point.

Very impressed with results

My patient just complained of mild soreness but did not require pain meds in pacu. No posterior knee pain.

On follow up pt stated he first started feeling pain at 29 hrs.

Thanks, SDN
 
There is nothing wrong in using a medication for an off label indication but there has to be some published data showing efficacy and safety.
For now the only data provided by the manufacturer is related to surgical site infiltration in hemorrhoids and bunions.
That's it!
Using it in any other indication is simply experimental until further literature is available.

And for some reason when people other than Jet start calling others "slim" it's just not too funny, but that might be just my perception!
 
Planktonmd said:
There is nothing wrong in using a medication for an off label indication but there has to be some published data showing efficacy and safety.
For now the only data provided by the manufacturer is related to surgical site infiltration in hemorrhoids and bunions.
That's it!
Using it in any other indication is simply experimental until further literature is available.

And for some reason when people other than Jet start calling others "slim" it's just not too funny, but that might be just my perception!
Click to expand...

There is plenty of data out there showing efficacy and safety of Exparel for TAP blocks. Several top medical centers are using it for that block as well. I did 2 more blocks with Exparel in the last 48 hours. I expect that I'll do dozens more over the next few weeks.

Experimental? Sorry Slim. I call it state of the art care.
 
BLADEMDA said:
There is plenty of data out there showing efficacy and safety of Exparel for TAP blocks. Several top medical centers are using it for that block as well. I did 2 more blocks with Exparel in the last 48 hours. I expect that I'll do dozens more over the next few weeks.

Experimental? Sorry Slim. I call it state of the art care.
Click to expand...

:beat:

There is really no point trying to have a debate with you since you are as everyone knows crazy!
Or is demented a better word?
 
Can you tell me what dose/dilution you are using for exparel in TAP blocks? I am also curious to know if you have used it for the thoracic paravertebral blocks? I am very interested in using it at my hospital... Any other blocks you have used it for? thanks.
 
Planktonmd said:
How do you know it's safe without any supporting data?
Click to expand...

We know bupivicaine is safe. We know that the liposome is VERY safe - even safe enough to place intrathecally (it is the same liposome they use to sell with morphine for intrathecal use - was it called depodur?)

The current nerve studies have shown it to be motor sparing - and very effective and as predicted...safe.

Planktonmd said:
You are not talking about Exparel are you?

You know that the drug has only been FDA approved for infitration and only for Hrmorrhoids and Bunions.
Click to expand...

Why would you care about FDA indication? You use a ton of drugs every day in the operating room that is not FDA approved. The FDA doesn't dictate physician practice.

Mman said:
They better not be as I'm pretty sure that violates federal law.
Click to expand...

Experal is FDA indicated for soft tissue infiltration. TAP is not a nerve block, it is a soft tissue infiltration. Just because ultrasound identifies the exact place for the soft tissue infiltration doesn't make it a nerve block. The reps are 100% within the bounds of the law on this.

The data the company has on cardiotoxicity (done in rats) is very compelling. It actually seems to have some protection when compared to bupivicaine alone.
 
Gas said:
Hi all, question for the regional experts. Some of our orthopods have said they do not want femoral nerve blocks for their TKR or ACL patients anymore, citing quadriceps weakness. I am not aware of femoral blocks contributing to quadriceps weakness, but I was wondering what others out there are doing.

At our small community hospital, we do a single shot, 20-30cc 0.25% marcaine with epi, half with U/S, half without. Some of our guys refuse to learn it. No catheters.

I haven't found much in the literature that says femoral blocks should be witheld for this reason, but some do say the block can be associated with quad weakness, but it seems like it would be caused by the surgery itself rather than the block. But better quad strength does lead to better surgical outcomes.

The orthopods cannot find the studies, nor do they know anything about what dose/concentration local, single shot vs. catheter, ultrasound vs. non-ultrasound. Go figure.
Click to expand...

There are so many questions about the ADC block that the current state of literature hasn't even begun to address.

First off - please tell me where the ADC is. No ultrasound paper clearly defines this. Under dissection I can find it but how do I know where it is under ultrasound? And also, is the adductor canal 10cm long? Is it only 2cm long? Do you have to actually be under the adductor canal aponeurosis or just under the sartorius somewhere or just next to the artery? If the canal is 10cm long - does it make a difference if I am near the entrance or near the distal end? A block 10cm above the knee is different than mid leg, or 2/3s up the leg from the knee. Those could all potentially be called "adductor canal" blocks because the artery and nerve is under the sartorious muscle for most of that distance.

How about volume? There are studies to show that dye can spread all the way up the inguinal region with a certain amount of volume. Won't that affect outcome studies?

I prefer the the term perifemoral approach to saphenous rather than adductor canal as a name for the block.
 
You must log in or register to reply here.

Similar threads

C
Nerve block pre existing deficit
Replies
31
Views
2K
DirtDocMD
D
S
Costoclavicular block
Replies
3
Views
742
crash2500
C
A
Buying a nerve stimulator for regional blocks
Replies
26
Views
2K
gunnershow
G
C
Nerve block, amide allergy
Replies
24
Views
2K
D P356
D
nimbus
Surgeon pays anesthesia for unused block time
Replies
25
Views
3K
Gern Blansten
Gern Blansten
Top