exparel for pnb's

[nap$ter]

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just curious how many folks are doing this (aside from blade).

i know that it's not FDA approved for PNB or neuraxial placement - this doesn't bother me. the FDA doesn't dictate our practice. we do many things that are not FDA approved.

our hospital has obtained some bottles of exparel and we are being encouraged to try it out in PNB's. the thing holding me back is the lack of data - there are virtually no studies on pubmed looking at PNB's with exparel, which i find.... odd. am i missing something or using the wrong search terms "liposomal bupivicaine" and "exparel"?

 

[drccw]

just curious how many folks are doing this (aside from blade).

i know that it's not FDA approved for PNB or neuraxial placement - this doesn't bother me. the FDA doesn't dictate our practice. we do many things that are not FDA approved.

our hospital has obtained some bottles of exparel and we are being encouraged to try it out in PNB's. the thing holding me back is the lack of data - there are virtually no studies on pubmed looking at PNB's with exparel, which i find.... odd. am i missing something or using the wrong search terms "liposomal bupivicaine" and "exparel"?

Who's encouraging you to perform a PNB with exparel? I've used it some for TAPs blocks but that's it... I'm all for off label use of ends (isobaric bupivicaine for spinals comes to mind) but I feel that this is a different beast... there's no data about what happens when a liposomal formulation is dumped onto a nerve... so I'm gonna wait for data.. Just imagine if one there was to be some neuro deficit after the pnb- you would be hosed...

drccw

 

[BLADEMDA]

In about 90 days Pacira should have the final data on their Femoral Nerve Block trial. The data shows it is safe and FDA approval is expected in 2014.

I've performed about 400 TAP nerve blocks with Exparel. Zero complications from the drug and I use additional Bup/Rop as well as needed.

 

[BLADEMDA]

Pacira Pharmaceuticals, Inc. ( PCRX ) submitted a Prior Approval Supplement (PAS) with the U.S. Food and Drug Administration (FDA) for an additional manufacturing site for Exparel.

Assuming that the FDA accepts the PAS for review, Prescription Drug User Fee Act (PDUFA) action date is expected in early Apr 2014.

Pacira's pain management drug Exparel is currently approved by the FDA for administration into the surgical site to produce postsurgical analgesia. The drug was approved by the FDA in the final quarter of 2011 and launched in Apr 2012.

Exparel generated $25.1 million of revenues in the first year of launch. In the third quarter of 2013, net Exparel revenues were $20 million, up 31.6% sequentially. At the end of Sep 2013, Exparel had a customer base of 1,732. Pacira reported an average of 23 new customers per week in the reported quarter.

Exparel is evaluated in two phase III nerve block studies - one where it is studied as a femoral nerve block for patients undergoing total knee arthroplasty while the other study evaluated the safety and efficacy of Exparel in intercostal nerve block for posterolateral thoracotomy. The first part of femoral nerve block study showed positive results and the final part is in progress. The intercostal nerve block study did not achieve its primary endpoint. As per FDA a single study meeting its primary endpoint is sufficient to gain approval for the nerve block indication. Pacira plans submit supplemental New Drug Application in early 2014.

Enrolment for a phase IV study in lower abdominal soft tissue surgeries is in progress. The program will evaluate the timing of the procedure as well as the dose and volume of Exparel, while measuring the opioid-sparing opportunity. Data from the study is expected by the end of 2013 or early 2014.



Read more: http://www.nasdaq.com/article/update-on-paciras-exparel-analyst-blog-cm309754#ixzz2tt1IamE0

 

[sevoflurane]

The verdict is out: TAP blocks work very well with Exparel. I presume that PNBs will follow... although I'm not sure if 2 day duration is what we want.

At this point you should NEVER use it for a lumbar epidural injection as it's a PARTICULATE formulation. Vertebral infarcts have occurred with depo-medrol.
Using them in this fashion is not wise IMHO. At least not until there is some good evidence out there.

 

[bostonblaz]

We have not tried it here as of yet however I think it will be something to look at. I have a colleague who was at one of the test sites for femoral nerve blocks and they had no issues. She did say that the motor block on some patients was as long as 48 hrs with an extended analgesic period of 72plus hours. Would love to see data on ISB and durations. Blaz

 

[Mman]

The verdict is out: TAP blocks work very well with Exparel. I presume that PNBs will follow... although I'm not sure if 2 day duration is what we want.

At this point you should NEVER use it for a lumbar epidural injection as it's a PARTICULATE formulation. Vertebral infarcts have occurred with depo-medrol.
Using them in this fashion is not wise IMHO. At least not until there is some good evidence out there.

I doubt there was a question of whether it would work or not. The questions will all relate to safety. Probably won't get enough trials to have reasonable data as to risk of nerve injury compared to baseline risk with other local anesthetics since you need a very large N to prove that. After a few years of widespread use, then we will know.

Also question with PNBs is how useful an extremely long block duration is.

 

[BLADEMDA]

The real indication for TKA isn't FEMORAL blocks but Adductor Canal. The trend is way from longer motor blocks like Femoral and towards sensory blocks.
Once approved I will be using Exparel for ISB, SCB, Adductor Canal, etc. on a routine basis for the right patients.

 

[sleepallday]

I've been pleased with the results with Exparel for TAP blocks. However, I've noticed that the Exparel reps are marketing this drug more to the orthopods than us. And are advising that Exparel be injected into the joint for total knees rather than doing femoral/adductor canal blocks. I am aware of a study currently underway comparing the two but it still is unfortunate that it seems Exparel has directed efforts of this drug away from the anesthesiologist.

Makes you wonder if they are concerned about some issues with injecting the drug into the nerve sheath.

 

[BLADEMDA]

I've been pleased with the results with Exparel for TAP blocks. However, I've noticed that the Exparel reps are marketing this drug more to the orthopods than us. And are advising that Exparel be injected into the joint for total knees rather than doing femoral/adductor canal blocks. I am aware of a study currently underway comparing the two but it still is unfortunate that it seems Exparel has directed efforts of this drug away from the anesthesiologist.

Makes you wonder if they are concerned about some issues with injecting the drug into the nerve sheath.

No. They don't have FDA approval for nerve blocks yet and are wary of pushing you to try an "experimental" local on your patients. Once they get FDA approval this year the reps will be back pushing hard for you to use Exparel.

 

[BLADEMDA]

For TKA, however, the real question in many anesthesiologists’ minds is: How can an injection of local anesthetic into the adductor canal by itself possibly provide enough analgesia for TKA?
The short answer is: it does not have to. Integrated multimodal analgesic protocols, as defined by the American Society of Anesthesiologists’ practice guidelines on perioperative pain management, use two or more analgesic modalities with different mechanisms of action to provide superior analgesia and limit side effects and adverse events.12 Regional analgesic techniques are usually at the center of these multimodal protocols in a background of nonsteroidal anti-inflammatory drugs, acetaminophen, and low-dose opioids.12 There is a nascent but growing case being made in the contemporary literature to support ACB as the most appropriate regional analgesic technique to be the core of a multimodal analgesic protocol for TKA due to its decreased potential for quadriceps weakness.13,14
The efficacy of ACB for TKA in the setting of oral multimodal analgesia has been previously demonstrated in a proof-of-concept study.15 Similarly, the addition of ACB to a multimodal protocol including local infiltration analgesia provides further improvement in pain scores and ambulation compared with placebo injection.16 Retrospective cohort studies further suggest that the combination of ACB and local infiltration analgesia is associated with enhanced early postoperative ambulation compared with femoral nerve perineural infusions.17,18


Editorial: Journal of Anesthesiology, March 2014

 

[sleepallday]

No. They don't have FDA approval for nerve blocks yet and are wary of pushing you to try an "experimental" local on your patients. Once they get FDA approval this year the reps will be back pushing hard for you to use Exparel.

FDA approval or not, if orthopods are a satisfied with intrarticular injection of Exparel (which it seems to me, they are), there will not be a need for femoral/adductor canal blocks for TKA's.

 

[Mman]

No. They don't have FDA approval for nerve blocks yet and are wary of pushing you to try an "experimental" local on your patients. Once they get FDA approval this year the reps will be back pushing hard for you to use Exparel.

In most states (as far as I know) it is illegal for a drug rep to suggest a non FDA approved use of a drug.

 

[BLADEMDA]

http://online.wsj.com/article/PR-CO-20140404-910402.html

I will start using Exparel for Nerve Blocks in the next few weeks. FDA approval is expected in the next few months based on this study.



EXPAREL Use in Femoral Nerve Block for Total Knee Arthroplasty Further Supported by Additional Data from Phase 3 Pivotal Study, sNDA Submission Planned for Second Quarter 2014

 

[RxBoy]

In about 90 days Pacira should have the final data on their Femoral Nerve Block trial. The data shows it is safe and FDA approval is expected in 2014.

I've performed about 400 TAP nerve blocks with Exparel. Zero complications from the drug and I use additional Bup/Rop as well as needed.

Our pharmacy would never let me perform a TAP block with a $285 bottle of exparel when bupivicaine costs $1. Ill stick to buprenorphine and decadron until that price comes down.

 

[heronmd]

The key findings are summarized below:
-- A 24 percent reduction in total opioid use in the EXPAREL group (P<0.05);
there was no significant difference between groups in the time to first
opioid rescue

that's an unimpressive result compared to placebo. Remember, they are comparing Exparel to saline here, NOT to regular bupivacaine

-- A greater number of patients who were "extremely satisfied" with pain
control in the EXPAREL group vs. placebo group at day 7 (55 percent vs.
43 percent) and day 30 (65 percent vs. 50 percent)

again, unimpressive
-- A statistically significantly higher percentage of "pain-free" patients
in the EXPAREL group (50 percent vs. 40 percent for placebo group at 60
hours; [P<0.05])

terribly unimpressive
This is an embarrassing result for Exparel. Can't understand why people think it's a good outcome....

 

[BLADEMDA]

The key findings are summarized below:
-- A 24 percent reduction in total opioid use in the EXPAREL group (P<0.05);
there was no significant difference between groups in the time to first
opioid rescue

that's an unimpressive result compared to placebo. Remember, they are comparing Exparel to saline here, NOT to regular bupivacaine

-- A greater number of patients who were "extremely satisfied" with pain
control in the EXPAREL group vs. placebo group at day 7 (55 percent vs.
43 percent) and day 30 (65 percent vs. 50 percent)

again, unimpressive
-- A statistically significantly higher percentage of "pain-free" patients
in the EXPAREL group (50 percent vs. 40 percent for placebo group at 60
hours; [P<0.05])

terribly unimpressive
This is an embarrassing result for Exparel. Can't understand why people think it's a good outcome....

All many of need who use Exparel on adaily basis is FDA approval. I know the drug works well just like an Extended release Bupivacaine. If you want good results then one must do the right type of nerve block. For Total knees a 90% reduction in Pain scores requires a Femoral plus Tibial or Popliteal block.

I highly recommend Exparel for TAP/SubCostal TAP blocks and have performed well over thousand so far with excellent results. I will use Exparel for other nerve blocks
in the future.

My plan is to ask Pharmacy to divide the Exparel under the hood into two doses so that the cost is reduced to about $140 per dose. Total Knee Patients would then get an Adductor Canal or Femoral Block with 10 mls (133 mg) of Exparel.

 

[nap$ter]

All many of need who use Exparel on adaily basis is FDA approval.

why?

 

[BLADEMDA]

FDA approval of Exparel for nerve blocks will encourage others to TAP blocks with the drug benefiting patients. In addition, I would be able to use the drug for Adductor Canal, Femoral, ICB and ISB blocks.

 

[nap$ter]

FDA approval of Exparel for nerve blocks will encourage others to TAP blocks with the drug benefiting patients. In addition, I would be able to use the drug for Adductor Canal, Femoral, ICB and ISB blocks.

i didn't think FDA approval was required prior to our use of drugs? ie dexmedetomidine is not approved for pediatrics but its use is common in that population...

i might be missing something...

 

[pgg]

I will start using Exparel for Nerve Blocks in the next few weeks. FDA approval is expected in the next few months based on this study.

What's the rush?

I'll read your experience with great interest, but I don't really get why you want to be one of the first to see if Exparel goes the way of Rapacuronium.

 

[pgg]

i didn't think FDA approval was required prior to our use of drugs? ie dexmedetomidine is not approved for pediatrics but its use is common in that population...

Technically the bupivacaine that comes in spinal kits isn't FDA approved for intrathecal use. Only morphine, baclofen, and ziconotide are.

We shouldn't be thinking of bupivacaine, dexmedetomidine, and Exparel as equally unknown entities, even if the FDA has the same non-opinion of them all.

 

[BLADEMDA]

What's the rush?

I'll read your experience with great interest, but I don't really get why you want to be one of the first to see if Exparel goes the way of Rapacuronium.

Exparel is safe. The question we must answer is this: is the drug worth $280 per dose?