Exparel for Nerve Blocks

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Article in this month's Anesthesiology Journal shows Exparel is safe and effective for Femoral nerve block.
48-72 hours of postop analgesia utilizing a single shot technique:

Fig. 6.
Proportion of subjects receiving liposome bupivacaine 266 mg (blue line) or placebo (red line) who reported being pain-free (numeric rating scale score of 0 or 1) through 72 h after total knee arthroplasty in study part 2. Asteriskindicates statistically significant (P < 0.005) between-group differences.
m_29FF06.png
 
Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117.
Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty.
Hadzic A1, Minkowitz HS, Melson TI, Berkowitz R, Uskova A, Ringold F, Lookabaugh J, Ilfeld BM.
Author information
  • 1From the Departments of Anesthesiology, St. Luke's and Roosevelt Hospitals, New York, New York, and Ziekenhouse Oost Limburgh, Genk, Belgium, and the New York School of Regional Anesthesia (NYSORA), New York, New York (A.H.); Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, Texas (H.S.M.); Department of Anesthesiology, Sheffield Anesthesia, Helen Keller Memorial Hospital, Sheffield, Alabama (T.I.M.); Department of Joint Replacement Surgery, University Hospital, Tamarac, Florida (R.B.); Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (A.U.); Veritas Research, LLC, Mobile, Alabama (F.R.); Pacira Pharmaceuticals, Inc., Parsippany, New Jersey (J.L.); and Department of Anesthesiology, University of California, San Diego, San Diego, California (B.M.I.).
Abstract
BACKGROUND:
The authors evaluated the efficacy of liposome bupivacaine in a femoral nerve block (FNB) after total knee arthroplasty.

METHODS:
Part 1: subjects received FNB with 20 ml liposome bupivacaine (67, 133, or 266 mg) or placebo. Part 2: subjects were randomized to FNB with liposome bupivacaine 266 mg or placebo. The primary outcome measure was area under the curve of the numeric rating scale score for pain intensity at rest through 72 h (AUC NRS-R0-72) with imputed scores after rescue medication.

RESULTS:
In part 1, FNB with liposome bupivacaine 266 mg (n = 24) resulted in analgesia similar to that obtained with 133 mg and was chosen for part 2. In part 2, least-squares mean (standard error) AUC NRS-R0-72 was lower with liposome bupivacaine 266 mg (n = 92) than with placebo (n = 91; 419 [17] vs. 516 [17]; P < 0.0001). This outcome remained unchanged in a post hoc analysis without score imputation (221 [12] vs. 282 [12]; P = 0.0005). Least-squares mean AUC NRS-R with imputed scores was lower with liposome bupivacaine during each 24-h interval (0 to 24, 24 to 48, and 48 to 72 h) after surgery; AUC NRS-R without imputed scores was lower during the 0- to 24-h and 24- to 48-h intervals. The liposome bupivacaine group had lower mean total opioid use (76 vs. 103 mg morphine; P = 0.0016). Pain was sufficiently severe to require second-step rescue with opioids via intravenously administered patient-controlled analgesia in 92% of liposome bupivacaine patients and 81% of placebo patients. With patient-controlled analgesia and other forms of rescue analgesia, mean NRS scores with activity were moderate in both liposome bupivacaine and placebo groups throughout the part 2 study period. Incidence of adverse events was similar between the groups (part 1: 90 vs. 96%; part 2: 96 vs. 96%, respectively).

CONCLUSION:
FNB with liposome bupivacaine (266 mg) resulted in modestly lower pain scores and reduced opioid requirements after surgery, with an adverse event profile similar to placebo.
 
Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117.
Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty.
Hadzic A1, Minkowitz HS, Melson TI, Berkowitz R, Uskova A, Ringold F, Lookabaugh J, Ilfeld BM.
Author information
  • 1From the Departments of Anesthesiology, St. Luke's and Roosevelt Hospitals, New York, New York, and Ziekenhouse Oost Limburgh, Genk, Belgium, and the New York School of Regional Anesthesia (NYSORA), New York, New York (A.H.); Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, Texas (H.S.M.); Department of Anesthesiology, Sheffield Anesthesia, Helen Keller Memorial Hospital, Sheffield, Alabama (T.I.M.); Department of Joint Replacement Surgery, University Hospital, Tamarac, Florida (R.B.); Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (A.U.); Veritas Research, LLC, Mobile, Alabama (F.R.); Pacira Pharmaceuticals, Inc., Parsippany, New Jersey (J.L.); and Department of Anesthesiology, University of California, San Diego, San Diego, California (B.M.I.).
Abstract
BACKGROUND:
The authors evaluated the efficacy of liposome bupivacaine in a femoral nerve block (FNB) after total knee arthroplasty.

METHODS:
Part 1: subjects received FNB with 20 ml liposome bupivacaine (67, 133, or 266 mg) or placebo. Part 2: subjects were randomized to FNB with liposome bupivacaine 266 mg or placebo. The primary outcome measure was area under the curve of the numeric rating scale score for pain intensity at rest through 72 h (AUC NRS-R0-72) with imputed scores after rescue medication.

RESULTS:
In part 1, FNB with liposome bupivacaine 266 mg (n = 24) resulted in analgesia similar to that obtained with 133 mg and was chosen for part 2. In part 2, least-squares mean (standard error) AUC NRS-R0-72 was lower with liposome bupivacaine 266 mg (n = 92) than with placebo (n = 91; 419 [17] vs. 516 [17]; P < 0.0001). This outcome remained unchanged in a post hoc analysis without score imputation (221 [12] vs. 282 [12]; P = 0.0005). Least-squares mean AUC NRS-R with imputed scores was lower with liposome bupivacaine during each 24-h interval (0 to 24, 24 to 48, and 48 to 72 h) after surgery; AUC NRS-R without imputed scores was lower during the 0- to 24-h and 24- to 48-h intervals. The liposome bupivacaine group had lower mean total opioid use (76 vs. 103 mg morphine; P = 0.0016). Pain was sufficiently severe to require second-step rescue with opioids via intravenously administered patient-controlled analgesia in 92% of liposome bupivacaine patients and 81% of placebo patients. With patient-controlled analgesia and other forms of rescue analgesia, mean NRS scores with activity were moderate in both liposome bupivacaine and placebo groups throughout the part 2 study period. Incidence of adverse events was similar between the groups (part 1: 90 vs. 96%; part 2: 96 vs. 96%, respectively).

CONCLUSION:
FNB with liposome bupivacaine (266 mg) resulted in modestly lower pain scores and reduced opioid requirements after surgery, with an adverse event profile similar to placebo.


This study is sponsored by the drug company.
Also it doesnt compare exparel to bupvicaine.
Also see the company sponsored study following dogs and rabbits injected with exparel who develop immune reaction to the liposome substance which can be seen in nerve adipose tissue. The company dismisses this finding.

I dont think the data is at the point where I would personally use it vs bupivicaine for a PNB. Maybe in time, maybe not.
 
I am still waiting for a study comparing Exparel to good old Bupivacaine! Or Bupivacaine + Dexamethasone!
I mean we know that Exparel is a better local anesthetic than placebo! but how about other significantly cheaper local anesthetics???
This company is starting to act the same way the BIS company acted when they tried to shove their product down our throat and claimed it was the best thing that happened to anesthesiology!
 
Exparel causes 20% reduction in narcotic use and 10% reduction in pain scores compared to normal saline? Damn that's terrible. I mean god awful. I can do the same study with regular bupivicaine or ropivicaine and show a bigger benefit. So Exparel is worse than the local anesthetics we already have?


On a related note, the truly terrible crap that can get published these days is amazing.
 
Exparel causes 20% reduction in narcotic use and 10% reduction in pain scores compared to normal saline? Damn that's terrible. I mean god awful. I can do the same study with regular bupivicaine or ropivicaine and show a bigger benefit. So Exparel is worse than the local anesthetics we already have?


On a related note, the truly terrible crap that can get published these days is amazing.

I disagree with you completely. Exparel is safe and effective. Whether it is better than Bupivacaine is for us to decide as specialists. All the FDA is required to do is approve safe and effective drugs. Whether it is cost-effective is another question entirely.

As for this particular study Total Knee Arthroplasty has a lot of discomfort due to the posterior knee pain. An Ipack injection with Exparel (diluted) will relieve that pain for more than 24 hours.

The key to my thread is that adverse events are the same with placebo vs Exparel.
 
This study is sponsored by the drug company.
Also it doesnt compare exparel to bupvicaine.
Also see the company sponsored study following dogs and rabbits injected with exparel who develop immune reaction to the liposome substance which can be seen in nerve adipose tissue. The company dismisses this finding.

I dont think the data is at the point where I would personally use it vs bupivicaine for a PNB. Maybe in time, maybe not.



EXPAREL (bupivacaine extended-release liposome injection), DepoFoam bupivacaine, is in development for prolonged postsurgical analgesia. Repeat-dose toxicity studies were conducted in rabbits and dogs to compare the potential local and systemic toxicities of EXPAREL and bupivacaine HCl (Bsol), and the reversibility of any effects. Dogs tolerated much larger doses than rabbits. EXPAREL-related minimal-to-moderate granulomatous inflammation was noted at the injection sites. In recovery animals, the granulomatous inflammation was observed less frequently and was characterized by an increased number of multinucleated giant cells. These effects were considered a normal response to liposomes and nonadverse. Rabbits are more sensitive than dogs. In rabbits, convulsions were noted with EXPAREL and more frequently with Bsol; a NOAEL was not identified. In dogs, EXPAREL was well tolerated (NOAEL > 30 mg/kg/dose). The cumulative exposure of EXPAREL in these studies is well in excess of the proposed maximum single-dose exposure that is intended in humans.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3189577/
 
I disagree with you completely. Exparel is safe and effective. Whether it is better than Bupivacaine is for us to decide as specialists. All the FDA is required to do is approve safe and effective drugs. Whether it is cost-effective is another question entirely.

As for this particular study Total Knee Arthroplasty has a lot of discomfort due to the posterior knee pain. An Ipack injection with Exparel (diluted) will relieve that pain for more than 24 hours.

The key to my thread is that adverse events are the same with placebo vs Exparel.

so it's great news that a very expensive drug is minimally better than placebo? Really? I mean it's statistically significant and clinically insignificant differences.
 
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How many patients to determine it "safe." Study seemed small.


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Does anyone know how to invest in the company that makes the placebo? Results are pretty good next to exparel. I expect there will be fierce competition among the two.

Yes, you could short PCRX. If you had done so this year you'd be up >40% YTD.
 
I disagree with you completely. Exparel is safe and effective. Whether it is better than Bupivacaine is for us to decide as specialists.
I'd rather see a good, randomized, blinded, prospective study determine if Exparel is better than bupivacaine or bupivacaine + dexamethasone.
 
I'd rather see a good, randomized, blinded, prospective study determine if Exparel is better than bupivacaine or bupivacaine + dexamethasone.

Sure, I agree with you. But, Exparel should be granted FDA approval as it is safe and as effective as Bupivacaine. The FDA agreed that Exparel met the safety aspect of approval but failed to demonstrate efficacy over placebo to their satisfaction.

We all can agree that an entire bottle of Exparel, 266 mg, is at least as effective as one bottle of 0.5% Bupivacaine. So, the concern most have on SDN is that Exparel isn't worth $300 vs $2.50 for a bottle of Bupivacaine. Again, that is something we can decide on as clinicians by doing studies and using the drug on our patients. But, until the FDA grants approval of Exparel for nerve blocks these randomized trials will be very slow to take place.
 
How many patients to determine it "safe." Study seemed small.


Sent from my iPad using SDN mobile app


I'd say N=50,000++ worldwide for the use of Exparel as the local anesthetic for TAP blocks. Many others like myself are also using Exparel for other sensory nerve blocks. The safety data is there despite those who refuse to see it.

I've utilized Exparel for Adductor canal blocks with the vast majority lasting for 48-72 hours.
 
I disagree with you completely. Exparel is safe and effective. Whether it is better than Bupivacaine is for us to decide as specialists. All the FDA is required to do is approve safe and effective drugs. Whether it is cost-effective is another question entirely.

As for this particular study Total Knee Arthroplasty has a lot of discomfort due to the posterior knee pain. An Ipack injection with Exparel (diluted) will relieve that pain for more than 24 hours.

The key to my thread is that adverse events are the same with placebo vs Exparel.
But this was compared to "SALINE".

The posterior knee pain is easily treated with a sciatic or popliteal block with regular stuff. Hell I use mepivicaine and they do exceptionally well. I want it to wear off long before PT gets their hands on the pt. it's not even necessary. But t does make them happy.
 
I'd say N=50,000++ worldwide for the use of Exparel as the local anesthetic for TAP blocks. Many others like myself are also using Exparel for other sensory nerve blocks. The safety data is there despite those who refuse to see it.

I've utilized Exparel for Adductor canal blocks with the vast majority lasting for 48-72 hours.
You and your "many others" can have at it. Im happy with my approach. And for what it's worth so is my administration who recently looked at EXPAREL vs my approach and even more so my surgeons.
 
We all can agree that an entire bottle of Exparel, 266 mg, is at least as effective as one bottle of 0.5% Bupivacaine.

No we can't. We can agree it's almost the same as placebo, but there is no study shown equivalent pain relief to regular old bupivicaine let alone superiority. I'd venture a guess that it's worse than bupivicaine because I guarantee they've already done it and not published the results.
 
Exparel IMO is good when you need volume i.e. tap blocks, local infiltration for tummy tucks, etc. Not necessarily when a regular LA would do just fine like PNBs.
 
No we can't. We can agree it's almost the same as placebo, but there is no study shown equivalent pain relief to regular old bupivicaine let alone superiority. I'd venture a guess that it's worse than bupivicaine because I guarantee they've already done it and not published the results.

Ridiculous post. It's a Liposomal Bupivacaine formulation which has been used clinical several hundred thousand times. Podiatrists know it lasts 24 hours. Hemorrhoids? works well as the local for injection (24 hours plus pain relief). Tap Blocks? Always lasts for more than 24 hours. Your post is clearly rubbish.
 
I actually think that advertising certain pharmaceuticals based on one's personal interests or affiliations on this forum is a violation of SDN policy!
And using offensive language against people who call you out on the nonsense you are spreading is less than professional!
 
A surgeon that has financial interest in a surgicenter buries that disclosure in a stack of paperwork boilerplate.

If an anesthesiologist owns stock in pacira and is an advocate for exparel, is that really a big issue?

Not picking sides here but how about a different perspective.
 
A surgeon that has financial interest in a surgicenter buries that disclosure in a stack of paperwork boilerplate.

If an anesthesiologist owns stock in pacira and is an advocate for exparel, is that really a big issue?

Not picking sides here but how about a different perspective.
It's a problem if he attempts to advertise his product here according to SDN policy.
 
Ridiculous post. It's a Liposomal Bupivacaine formulation which has been used clinical several hundred thousand times. Podiatrists know it lasts 24 hours. Hemorrhoids? works well as the local for injection (24 hours plus pain relief). Tap Blocks? Always lasts for more than 24 hours. Your post is clearly rubbish.

I'm nearly certain Exparel is worse for nerve blocks. Any and all supportive data behind it's use are for field blocks/wound infiltration.
 
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It's a problem if he attempts to advertise his product here according to SDN policy.

1. I don't own any stock in Pacira- not even one share
2. I own stock in a very small biotech competitor to Pacira whose product is not even on the market yet
3. My group has used several thousand bottles of Exparel with excellent results and ZERO adverse avents that we are aware of.
4. Facts are facts and those who don't use the product regularly are the ones bashing it
5. I've used Exparel on friends, family members, physicians, etc with excellent results.


http://www.nysora.com/exparel/pdfs/asrasupraclav.pdf

http://epostersonline.s3.amazonaws.com/asras2015/asras2015.129016f.NORMAL.pdf
 
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Promising Results for Liposomal Bupivacaine Use in Shoulder Surgery
Interscalene brachial plexus blockade (ISB) has notable risks for the patient, and at the recent 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons, 3 studies evaluated liposomal bupivacaine as potential alternative to ISB for postoperative analgesia following anatomic and reverse shoulder arthroplasty.

The results mostly demonstrated equivalent pain control for the 2 techniques. One study also showed liposomal bupivacaine to be considerably safer (ie, fewer complications) and to cost less than ISB.

The first, a pilot study conducted by Angel et al, included 61 consecutive shoulder arthroplasty patients who received either ISB (n=31) or liposomal bupivacaine injection (n=31; 20 mL liposomal bupivacaine mixed with 30 mL bupivacaine, buffered with 30 mL saline).

The groups had similar pain scores, except on POD1 when the liposomal bupivacaine group had significantly less pain. No significant differences were seen between groups in patient satisfaction or length of stay.

The researcher said they believe that as they gained more clinical experience with the liposomal bupivacaine technique, they saw better pain outcomes. They modified the injection technique: They used a longer needle to slow down the injection into deeper tissues, they focused on infiltration around the suprascapular nerve, and they included 3 distinct injection times during the procedure.

The second study by Namdari et al was a randomized controlled trial that included 106 shoulder arthroplasty patients who received either ISB (n=53) or intraoperative infiltration with liposomal bupivacaine (n=53; 20 mL liposomal bupivacaine with 20 mL saline).

Results over 24 hours showed that the liposomal bupivacaine patients needed more opioids intraoperatively, but after surgery, the amount of opioid consumption was equivalent between the 2 groups. ISB patients had lower early pain scores (at 0 and 8 hours postoperatively), but liposomal bupivacaine patients had lower scores later (at 16 and 24 hours).

The third study by Weller et al retrospectively reviewed 214 shoulder arthroplasty procedures performed by a single surgery. The study evaluated pain, morphine consumption, complications, and cost. A total of 156 patients were treated with an ISB and 58 patients were treated with periarticular liposomal bupivacaine.

The researchers found no difference in short-term (24 hours) or long-term (up to 12 weeks) pain between the groups. The liposomal bupivacaine group required nearly twice as much morphine as the ISB group during the first 24 hours, but there was no significant difference in the cumulative amount of outpatient opioid use.

Twenty major complications occurred in the ISB group (including respiratory distress, catheter incarceration, and recalcitrant brachial neuritis) compared with 2 major complications in the liposomal bupivacaine group (pulmonary embolism and readmission for repeated falls).

A cost analysis found that the charges for the liposomal bupivacaine were more than $1000 less per case than for ISB.

Sources


Angel JD, SteeL C, Ong K, Watson H, Lovald ST. Pain control after total and reverse shoulder arthroplasty: interscalene block vs. liposomal bupivacaine (Poster 315).

Namdari S, Nicholson TA, Abboud JA, Lazarus MD, Steinberg D, Williams Jr GR. Randomized controlled trial of interscalene block vs. injectable liposomal bupivacaine in shoulder arthroplasty (Paper 089).

Weller WJ, Azzam MJ, Azar FM, Smith RA, Throckmorton TW. Liposomal bupivacaine: equal pain relief and less complication versus interscalene block in shoulder arthroplasty (Paper 090).

All presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons, March 1-5, 2016, in Orlando, Florida.
 
Promising Results for Liposomal Bupivacaine Use in Shoulder Surgery

The results mostly demonstrated equivalent pain control for the 2 techniques. One study also showed liposomal bupivacaine to be considerably safer (ie, fewer complications) and to cost less than ISB.

The first, a pilot study conducted by Angel et al, included 61 consecutive shoulder arthroplasty patients who received either ISB (n=31) or liposomal bupivacaine injection (n=31; 20 mL liposomal bupivacaine mixed with 30 mL bupivacaine, buffered with 30 mL saline).

The groups had similar pain scores, except on POD1 when the liposomal bupivacaine group had significantly less pain. No significant differences were seen between groups in patient satisfaction or length of stay.

I thought mixing Exparel with Bupivacaine was not recommended by the manufacturer and it changes the characteristics of the liposomal preparation!
Also If some one is saying that in POD#1 the infiltration with this magical potion provided better analgesia than ISB they must not know how to do an ISB properly!
Now... if you are paid to produce certain results it's very easy to do a crappy ISB so the company will continue to pay you... just disgusting!
 
Promising Results for Liposomal Bupivacaine Use in Shoulder Surgery
Interscalene brachial plexus blockade (ISB) has notable risks for the patient, and at the recent 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons, 3 studies evaluated liposomal bupivacaine as potential alternative to ISB for postoperative analgesia following anatomic and reverse shoulder arthroplasty.

The results mostly demonstrated equivalent pain control for the 2 techniques. One study also showed liposomal bupivacaine to be considerably safer (ie, fewer complications) and to cost less than ISB.

The first, a pilot study conducted by Angel et al, included 61 consecutive shoulder arthroplasty patients who received either ISB (n=31) or liposomal bupivacaine injection (n=31; 20 mL liposomal bupivacaine mixed with 30 mL bupivacaine, buffered with 30 mL saline).

The groups had similar pain scores, except on POD1 when the liposomal bupivacaine group had significantly less pain. No significant differences were seen between groups in patient satisfaction or length of stay.

The researcher said they believe that as they gained more clinical experience with the liposomal bupivacaine technique, they saw better pain outcomes. They modified the injection technique: They used a longer needle to slow down the injection into deeper tissues, they focused on infiltration around the suprascapular nerve, and they included 3 distinct injection times during the procedure.

The second study by Namdari et al was a randomized controlled trial that included 106 shoulder arthroplasty patients who received either ISB (n=53) or intraoperative infiltration with liposomal bupivacaine (n=53; 20 mL liposomal bupivacaine with 20 mL saline).

Results over 24 hours showed that the liposomal bupivacaine patients needed more opioids intraoperatively, but after surgery, the amount of opioid consumption was equivalent between the 2 groups. ISB patients had lower early pain scores (at 0 and 8 hours postoperatively), but liposomal bupivacaine patients had lower scores later (at 16 and 24 hours).

The third study by Weller et al retrospectively reviewed 214 shoulder arthroplasty procedures performed by a single surgery. The study evaluated pain, morphine consumption, complications, and cost. A total of 156 patients were treated with an ISB and 58 patients were treated with periarticular liposomal bupivacaine.

The researchers found no difference in short-term (24 hours) or long-term (up to 12 weeks) pain between the groups. The liposomal bupivacaine group required nearly twice as much morphine as the ISB group during the first 24 hours, but there was no significant difference in the cumulative amount of outpatient opioid use.

Twenty major complications occurred in the ISB group (including respiratory distress, catheter incarceration, and recalcitrant brachial neuritis) compared with 2 major complications in the liposomal bupivacaine group (pulmonary embolism and readmission for repeated falls).

A cost analysis found that the charges for the liposomal bupivacaine were more than $1000 less per case than for ISB.

Sources


Angel JD, SteeL C, Ong K, Watson H, Lovald ST. Pain control after total and reverse shoulder arthroplasty: interscalene block vs. liposomal bupivacaine (Poster 315).

Namdari S, Nicholson TA, Abboud JA, Lazarus MD, Steinberg D, Williams Jr GR. Randomized controlled trial of interscalene block vs. injectable liposomal bupivacaine in shoulder arthroplasty (Paper 089).

Weller WJ, Azzam MJ, Azar FM, Smith RA, Throckmorton TW. Liposomal bupivacaine: equal pain relief and less complication versus interscalene block in shoulder arthroplasty (Paper 090).

All presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons, March 1-5, 2016, in Orlando, Florida.


so your beneficial evidence for nerve blocks is 3 small studies of wound infiltration?
 
I thought mixing Exparel with Bupivacaine was not recommended by the manufacturer and it changes the characteristics of the liposomal preparation!
Also If some one is saying that in POD#1 the infiltration with this magical potion provided better analgesia than ISB they must not know how to do an ISB properly!
Now... if you are paid to produce certain results it's very easy to do a crappy ISB so the company will continue to pay you... just disgusting!
My understanding is that you can mix it with bupivacaine since it is in equilibrium with the bupi in the liposomes. Any other local anesthetic will bring the bupi out of the liposomes, maybe reaching toxic levels, when the liposomes equilibrate with the new local anesthetic/bupi mixture.
 
Blade, a simple head-to-head study comparing a PNB with Exparel to a PNB with bupivacaine (and maybe a 3rd arm with bupivacaine + dexamethasone) is the easiest study in the world to set up and do.

Blocks are not rare procedures. The results are easy to quantify. It would take a short time to gather a lot of good quality data directly comparing the two.

If Exparel is clearly superior to bupivacaine and/or bupivacaine + dexamethasone ... why isn't it obviously supported by published research? Why are we having this discussion?

Publication bias?
 
Publication bias!

I fixed the punctuation for you on the end of your post. The problem is the only people really paying for the research on Exparel is Pacira. They have a vested interest in making sure any negative trials don't get published.
 
Blade, a simple head-to-head study comparing a PNB with Exparel to a PNB with bupivacaine (and maybe a 3rd arm with bupivacaine + dexamethasone) is the easiest study in the world to set up and do.

Blocks are not rare procedures. The results are easy to quantify. It would take a short time to gather a lot of good quality data directly comparing the two.

If Exparel is clearly superior to bupivacaine and/or bupivacaine + dexamethasone ... why isn't it obviously supported by published research? Why are we having this discussion?

Publication bias?

Blade's point is that to get the comparison studies - we need FDA approval first. This is a discussion that deserves it's own thread, but it is absolutely disgusting what our journals have done (think RAPM). They have come out and clearly said they will not publish studies with drugs that are off - label. This basically puts an end to good science - so now the ONLY drugs that can be studied are funded studies with FDA blessing - which means only big pharma gets to play. I have no idea why RAPM would be in the pockets of big pharma.

If I wanted to do a head to head study as you suggest - first of all, only smaller journals would publish unless I get an IND. My IRB probably wouldn't even allow me to do the study without an IND. Can I get an IND? HELL NO. The requirements and expenses are huge. The ONLY way I could get an IND is with the help of deep pockets.

The whole thing is very very upsetting. So much so that I will never submit another article/letter to RAPM or Anesthesiology. I will never attend another ASRA meeting. I will secretly talk bad about the people in charge and I will complain bitterly to my children who don't know what I am talking about. (although full disclosure, my name was on a paper recently accepted to RAPM but I had no say in where it was submitted.)

With regards to Exparel, I'm sad many of you don't like it or won't use it. I think it is a pretty great drug. I think there is a lot of work to do - to figure out where and when to use it best, but I think it is pretty amazing that you can have a local anesthetic slowly infuse over 72 hours.
 
If I wanted to do a head to head study as you suggest - first of all, only smaller journals would publish unless I get an IND. My IRB probably wouldn't even allow me to do the study without an IND. Can I get an IND? HELL NO. The requirements and expenses are huge. The ONLY way I could get an IND is with the help of deep pockets.

Investigational New Drug approval is for drugs that have not been approved for use yet. Using Exparel in a PNB likely does not require any IND in a study situation per FDA recommendations. Alternatively, off label uses could be analyzed retrospectively.
 
Investigational New Drug approval is for drugs that have not been approved for use yet. Using Exparel in a PNB likely does not require any IND in a study situation per FDA recommendations. Alternatively, off label uses could be analyzed retrospectively.

I've got N=1,000 of "restrospective data showing excellent results for Tap blocks. In addition, I'm now using it for other sensory blocks with very good results. I can understand the caution here about Exparel but the claims about it being not effective (it's as least as effective as Bupivacaine) or unsafe are completely false.

Once Pacira obtains FDA approval for Exparel the double blinded randomized studies will be done and I will start using it for many more PNBs.

I'm not certain the $300 cost per 266 mg vial of Exparel is worth it over $4.00 Bupivacaine plus Dexamethasone in most situations but Exparel does have a role to play in our specialty.
 
Investigational New Drug approval is for drugs that have not been approved for use yet. Using Exparel in a PNB likely does not require any IND in a study situation per FDA recommendations. Alternatively, off label uses could be analyzed retrospectively.

This isn't true at all. If you want to do an off-label study, you can apply for an IND waiver, and I have been granted those before. However, there is NO WAY the FDA would grant a waiver for nerve block on this drug. You would definitely need an IND.

Retrospect doesn't answer the question. We just published our retrospective data on TAP blocks - it's cool stuff, but it isn't a randomized trial. People rarely change practice based on retrospective data.
 
Had an OB use Exparel for local infiltration after a c section. Seemed like a big waste to me, anyone else have surgeons use it for incisions?
 
I've got N=1,000 of "restrospective data showing excellent results for Tap blocks. In addition, I'm now using it for other sensory blocks with very good results. I can understand the caution here about Exparel but the claims about it being not effective (it's as least as effective as Bupivacaine) or unsafe are completely false.

Once Pacira obtains FDA approval for Exparel the double blinded randomized studies will be done and I will start using it for many more PNBs.

I'm not certain the $300 cost per 266 mg vial of Exparel is worth it over $4.00 Bupivacaine plus Dexamethasone in most situations but Exparel does have a role to play in our specialty.
By the way I am almost 100% sure that you are lying when you said that you have no Pacira shares! I don't have time to search it now but you have previously stated that you are a share holder and you were encouraging people to invest in their failing endeavor.
 
By the way I am almost 100% sure that you are lying when you said that you have no Pacira shares! I don't have time to search it now but you have previously stated that you are a share holder and you were encouraging people to invest in their failing endeavor.
Ouch!
 
Pain Medicine
MAY 11, 2016
Liposomal Bupivacaine After TKA Reduces Hospital Stay


Orlando, Fla.—Patients receiving liposomal bupivacaine (Exparel, Pacira) injection after total knee arthroplasty (TKA) spent less time in the hospital and were significantly less likely to need to go to a rehabilitation center after discharge, a recent study found.

Patients given liposomal bupivacaine spent a half-day less in the hospital than those administered routine, opioid-based pain medications, according to the review of patient records by researchers at Philadelphia College of Osteopathic Medicine; Plano Orthopedics and Sports Medicine, in Texas; and the Rubin Institute for Advanced Orthopedics at the Sinai Hospital of Baltimore.

“The results of this analysis are encouraging because they suggest that the use of [liposomal bupivacaine] not only allows us to get our patients up and out of the hospital sooner, but also increases the likelihood we can send them directly home,” said Michael Mont, MD, director of the Center for Joint Preservation and Replacement at the Rubin Institute for Advanced Orthopedics, and an author of the poster.

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The study was presented at the American Academy of Orthopaedic Surgeons 2016 annual meeting, and was supported by Pacira Pharmaceuticals.

Very Large Retrospective Study

The retrospective analysis examined records from the Premier hospital discharge database, looking at patients aged 18 years and older who underwent TKA between July 1, 2013, and June 30, 2014.

The study compared hospitalization duration and discharge information between 80,160 patients who were treated with standard analgesics and 14,668 patients who received liposomal bupivacaine.

The liposomal bupivacaine cohort consisted of 9,211 women and 5,457 men, and there were 49,699 women and 30,461 men in the group receiving the standard pain treatment regimen. The mean age in both groups was 66 years.

The hospital length of stay (LOS) analysis used a linear model with a negative binomial distribution, controlled for age, sex, race, geographic region, Charlson Comorbidity Index and operating time, according to the study. The discharge analysis—the percentage of patients who went directly home—used logistic regression with the same controls.

Liposomal bupivacaine is administered in a single dose and injected into the surgical site, with bupivacaine releasing over time. The product pairs bupivacaine with DepoFoam, a delivery technology.

Shorter Hospital LOS, Modest Cost Savings

Liposomal bupivacaine patients stayed in the hospital 2.58 days, compared with 2.98 for the group given standard pain medications. Of patients receiving liposomal bupivacaine, 73.2% were discharged directly to home, compared with 66% of those treated with routine analgesics.

“The ability to recover at home, rather than in a short-term nursing facility or rehabilitation center, not only lends itself to favorable hospital economics, but also—importantly—toward a more comfortable patient recovery experience,” said Dr. Mont.

The study suggests that liposomal bupivacaine has the potential to be an alternative to standard pain treatments, which often use opioids with their attendant side effects, including nausea, vomiting and respiratory depression, all of which can lead to longer hospital LOS followed by rehab therapy.

“These results are encouraging and suggest that liposomal bupivacaine may represent a promising addition to current multimodal pain management regimens,” the study noted.

Although costs were not examined in-depth, there was a modest savings of $300 per patient per day in the liposomal bupivacaine group. While this is not a huge number on an individual basis, collectively the savings could add up.

“If you have a savings of $300 per day at a hospital that provides this treatment for 1,000 patients yearly, on a national level, I think it’s pretty substantial,” said Jaydev Mistry, MD, an orthopedic research fellow to Dr. Mont.

Study Limitations

Despite the positive findings, Gaurav Rajpal, MD, assistant professor at the University of Massachusetts Medical School, in Worcester, said he found some limitations with the study.

Because it was a retrospective study, Dr. Rajpal noted that it is not clear what factors were considered when deciding whether to give a patient liposomal bupivacaine.

There was also no information on how much of the drug different patients received, nor any discussion of rescue analgesics or how the two groups fared on pain scores.

Based on these issues, he argued that t he study does not provide enough data on which to base a conclusion. “We need a large prospective study,” Dr. Rajpal said.

In contrast, although Adriana Desillier, MD, an anesthesiologist at Tufts Medical Center, in Boston, agreed the study had some limitations as a retrospective analysis, she was encouraged by the data.

Dr. Desillier sees the potential for reducing reliance on opioid pain medications and for potentially lower costs by reducing hospital LOS.

“This is a very interesting and promising study,” Dr. Desillier said. “It definitely provides some guidance on the use of liposomal bupivacaine while at the same time reducing the cost by decreasing [hospital LOS].”
 
By the way I am almost 100% sure that you are lying when you said that you have no Pacira shares! I don't have time to search it now but you have previously stated that you are a share holder and you were encouraging people to invest in their failing endeavor.

Hold it ... please don't just throw around comments like this. I don't recall ever reading him say he bought PCRX. We've had a lot of financial and stock threads here over the years, and if anything he's migrated from being a stock picker to an index fund owner. (dr doze has had that effect on some of us ...)

Either say nothing, or back it up with a link to a comment.

I just spent a few minutes looking via a google search for "pacira blademda site:studentdoctor.net" and "PCRX blademda site:studentdoctor.net" ...

The closest any of his posts ever come to referring to a purchase of PCRX is this one, in which he comments on if he ever did, he wouldn't buy much:

On May 3, 2015:
I'm a former Wordlcom stock holder along with Sun Microsystems and several others. Those days are behind me as now I have a well diversified portfolio consisting of Equities and Fixed Income/Bonds. Vanguard ETFs are the mainstay of my Portfolio along with a few others. My tax-deferred side is primarily 4 and 5 star Mutual Funds (as recommended by Morningstar.com) to achieve even more diversification in the Global/Foreign Real estate market, Emerging Markets especially the Asian emerging market. In addition, I use active Bond management on the tax-deferred side of my portfolio.

For a small company stock like PCRX I would never invest more than 0.5% of my portfolio and likely far less. The key to successful long term investing is good stewardess of your money which means low cost combined with diversification. I utilize ETFs for that purpose these days and am very satisfied with the cost vs performance issue not to mention the benefits of avoiding taxes on capitals gains from the ETFs.

In my tax bracket it was either ETFs, Index Funds or Individual equities for the taxable side of my portfolio and I chose the ETF route for my core holdings. I still own several large positions from the market crash of '09 in GE, Home Depot, Wells Fargo, Exxon, Chevron, Apple, American Express etc and these stocks will be held until I see a fundamental reason to sell them.

I will likely sell Apple at some point as that company hits a Trillion dollars in market cap; I will still have exposure to Apple through my ETFs.


http://www.forbes.com/sites/rickferri/2012/07/02/three-keys-to-greater-wealth/ (read)


https://www.betterment.com/
https://www.personalcapital.com/


We can be skeptical of Exparel and Pacira's prospects without getting all snarly about it.
 
Incidentally, some fun reading through those old stock picking threads.

I'm more convinced than ever that one shouldn't get their stock picking advice off a board full of doctors ... 🙂

Some of the more concrete predictions:


On March 10, 2013:
I'd say the odds of Pacira hitting $50 in the next 3 years is pretty good. 80% chance it hits $50 in 36 months.
He was right ... hit $50 in Oct 2013. Peaked at$117 in February 2015.

On August 16, 2014:
Pacira reports ...once again...large increase in sales over last quater...huge actually.

I recently spoke with the CEO... He thinks they have reached 2% of the market they will eventually reach.

My point is...after today's sell off, it is an excellent entry point for those of you who see clearly.
Pacira was about $100 then. Now it's at $45.

On October 30, 2014:
Buying opportunity.
Pacira was at $92 that day.

On April 30, 2015:
PCRX's 10-Q was released today. I haven't sifted through the document to see how the earnings matched up with the expected $0.20/share, but I'm guessing they fell short if there was a 16% dip today. Moreover, looks like recently analysts have downgraded this stock and are recommending an avoid for now. My thought is that the price will continue to fall for the next month or so, but will show a substantial gain by Q4 2015.

....that's just my thoughts though, I'm no expert :ninja:
Pacira had just dipped below $70 in April 2015, after its peak of $117 two months earlier. Where was it by Q4 2015? Well, in October it was $37. before briefly flirting with the $70s in December.

$45 today.
 
Incidentally, some fun reading through those old stock picking threads.

I'm more convinced than ever that one shouldn't get their stock picking advice off a board full of doctors ... 🙂

Some of the more concrete predictions:


On March 10, 2013:

He was right ... hit $50 in Oct 2013. Peaked at$117 in February 2015.

On August 16, 2014:

Pacira was about $100 then. Now it's at $45.

On October 30, 2014:

Pacira was at $92 that day.

On April 30, 2015:

Pacira had just dipped below $70 in April 2015, after its peak of $117 two months earlier. Where was it by Q4 2015? Well, in October it was $37. before briefly flirting with the $70s in December.

$45 today.

Well the price went up over 25% in the months after I stated that it was a buying opportunity at 92. I failed to post the time to sell, which was at 117, but I cant give away all my secrets.
 
OK... Maybe it's just my imagination... maybe he has no affiliation with Pacira and I am just being mean to him... thank you PGG !
Some times though if it looks like a duck it's most likely a duck my gullible friend!
 
This isn't true at all. If you want to do an off-label study, you can apply for an IND waiver, and I have been granted those before. However, there is NO WAY the FDA would grant a waiver for nerve block on this drug. You would definitely need an IND.

Retrospect doesn't answer the question. We just published our retrospective data on TAP blocks - it's cool stuff, but it isn't a randomized trial. People rarely change practice based on retrospective data.

Not true. You only need an IND if you think the new route of administration significantly increases the risk of the drug and it's an individual IRB issue, not an FDA issue. Also, while it's true a retrospective analysis doesn't "answer the question", it begs the question why there hasn't been one published that suggests the answer. Because the data is out there and Pacira would pay people to publish it if it helped their cause.
 
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I am a podiatrist. I have used exparel and have decided bupivacaine is better for foot blocks. It all started when I blocked a bunion patient who had pain on post op day 2. I promised at least a full 24 hours of relief (I forget why he opted for this over oral narcotics ). He said the exparel effect was minimal. So I did a block on my own foot, and wasn't impressed with the effect, early or late. The block wasn't really solid, and yes I have done many of the fundamental local blocks on my own feet, kinda weird I know.
 
I am a podiatrist. I have used exparel and have decided bupivacaine is better for foot blocks. It all started when I blocked a bunion patient who had pain on post op day 2. I promised at least a full 24 hours of relief (I forget why he opted for this over oral narcotics ). He said the exparel effect was minimal. So I did a block on my own foot, and wasn't impressed with the effect, early or late. The block wasn't really solid, and yes I have done many of the fundamental local blocks on my own feet, kinda weird I know.

Awesome dude!

And good info.
 
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