Stock in Pacira Pharmaceuticals (PCRX)

[BLADEMDA]

New York—Researchers seeking to reduce the duration of postoperative pain and opioid consumption in patients undergoing orthopedic surgery recently reported some promising findings: In a phase 3 trial designed to meet FDA standards for approval, investigators demonstrated that liposomal bupivacaine (Exparel, Pacira) administered as a single-injection nerve block significantly reduced pain and decreased or eliminated opioid consumption 48 hours after surgery in patients undergoing shoulder surgery.

“There is a significant difference in the pain experience through those first 48 hours,” said study co-author Jeffrey Gadsden, MD, associate professor of anesthesiology at Duke University School of Medicine, in Durham, N.C. “If you summed it all up, there was a roughly 46% reduction in pain intensity in the treatment group versus the placebo group.”

Moreover, there was a 77% reduction in opioid consumption over 48 hours among patients who received liposomal bupivacaine compared with those who received placebo. Dr. Gadsden referred to this as “a huge issue now in the era of the opioid crisis,” noting the value of any interventions that can potentially reduce opioid use.





Wanted: Longer, Safer Pain Relief

The duration of pain relief provided by traditional nerve blocks is limited, and there are other shortcomings. “Brachial plexus block works really well for shoulder surgery; it’s the gold standard for how we manage pain,” Dr. Gadsden said. But, he added, “single-shot blocks don’t last very long; the pain outlasts the block. Catheter techniques work well, but catheters have problems—they get displaced, they fall out, they kink.”

Dr. Gadsden presented the current findings on liposomal bupivacaine at the New York School of Regional Anesthesia 2017 Annual Symposium on Regional Anesthesia, Pain and Perioperative Medicine (abstract NYS25). This phase 3, multicenter, randomized, double-blind, placebo-controlled trial included adult patients undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair at 17 sites in Belgium, Denmark and the United States. All patients had an ASA physical status of I, II or III, and were randomly assigned 1:1:1 to receive liposomal bupivacaine (133 or 266 mg) administered as an ultrasound-guided single-injection brachial plexus block at least one hour before surgery, or placebo.

Following an interim pharmacokinetic analysis that demonstrated the efficacy of the 133-mg dose, investigators decided to randomly assign all future patients to receive the lower dose. One hundred forty patients were included in the final efficacy and safety analyses (n=69, 133 mg of liposomal bupivacaine; n=71, placebo); the 15 patients who received 266 mg of liposomal bupivacaine were included in the safety and pharmacokinetic analyses.

Liposomal bupivacaine significantly reduced pain intensity through 48 hours post-surgery—the primary outcome of the study—by 46% compared with placebo (P<0.0001), as measured by the mean area under the curve of visual analog scale pain intensity scores. Additionally, significantly more patients who received liposomal bupivacaine had no pain in the PACU compared with patients who received placebo (18 vs. two, respectively; P<0.0001), a trend that also was significant at 24 and 48 hours post-surgery (four vs. zero for both time points; P=0.04 for both).

Postoperative opioid consumption through 48 hours—a secondary study end point—was reduced significantly (by 77%) in recipients of liposomal bupivacaine versus placebo (P<0.0001). Time to first opioid rescue was significantly longer among patients who received liposomal bupivacaine compared with those who received placebo (4.2 vs. 0.6 hours, respectively; P<0.0001). Significantly more patients who received liposomal bupivacaine remained opioid-free at 24 hours (16 vs. one; P=0.0001) and 48 hours (nine vs. one; P=0.008) compared with patients who received placebo. Statistical significance was not maintained at 72 hours (four vs. one; P=0.16).

Safety and tolerability profiles of liposomal bupivacaine were comparable with placebo. Sensory function returned to baseline within 60 hours after surgery in patients who received liposomal bupivacaine, with most patients experiencing only a transient loss of sensation. Motor function resolved within 48 hours post-surgery in both the liposomal bupivacaine and placebo groups.

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[Mman]

New York—Researchers seeking to reduce the duration of postoperative pain and opioid consumption in patients undergoing orthopedic surgery recently reported some promising findings: In a phase 3 trial designed to meet FDA standards for approval, investigators demonstrated that liposomal bupivacaine (Exparel, Pacira) administered as a single-injection nerve block significantly reduced pain and decreased or eliminated opioid consumption 48 hours after surgery in patients undergoing shoulder surgery.

“There is a significant difference in the pain experience through those first 48 hours,” said study co-author Jeffrey Gadsden, MD, associate professor of anesthesiology at Duke University School of Medicine, in Durham, N.C. “If you summed it all up, there was a roughly 46% reduction in pain intensity in the treatment group versus the placebo group.”

Moreover, there was a 77% reduction in opioid consumption over 48 hours among patients who received liposomal bupivacaine compared with those who received placebo. Dr. Gadsden referred to this as “a huge issue now in the era of the opioid crisis,” noting the value of any interventions that can potentially reduce opioid use.





Wanted: Longer, Safer Pain Relief

The duration of pain relief provided by traditional nerve blocks is limited, and there are other shortcomings. “Brachial plexus block works really well for shoulder surgery; it’s the gold standard for how we manage pain,” Dr. Gadsden said. But, he added, “single-shot blocks don’t last very long; the pain outlasts the block. Catheter techniques work well, but catheters have problems—they get displaced, they fall out, they kink.”

did they seriously use placebo as the control? That seems both barbaric and bad from a clinical point of view. I'd rather know how much opioid it spares compared to something like bupivacaine or ropivacaine.

 

[BLADEMDA]

did they seriously use placebo as the control? That seems both barbaric and bad from a clinical point of view. I'd rather know how much opioid it spares compared to something like bupivacaine or ropivacaine.

I have used Exparel for years on over 1,000 patients. My findings are well documented on SDN and line up with Gadsen's 100%.


MARCH 6, 2018
Liposomal Bupivacaine Nerve Block Possible ‘Game Changer’ in Shoulder Surgery, Pending FDA Ruling

 

[Mman]

I have used Exparel for years on over 1,000 patients. My findings are well documented on SDN and line up with Gadsen's 100%.

I'm curious why they didn't do a clinically relevant control group. Nobody really cares (including probably the FDA) if it is better than placebo.

 

[BLADEMDA]

I'm curious why they didn't do a clinically relevant control group. Nobody really cares (including probably the FDA) if it is better than placebo.

The drug works period. I highly recommend it to control pain beyond 30 hours. I'd recommend it for my family members or myself.

 

[facted]

The drug works period. I highly recommend it to control pain beyond 30 hours. I'd recommend it for my family members or myself.

That's great. Bupi and dex works great too.

I'm with @Mman. Placebo controlled trial is a joke, and in fact, it's part of the FDA reasoning to deny approval for PNB at this time.

Pacira is CLEARLY afraid exparel is really no better than bupi (and forget about bupi/dex) or else they would compare it to current standard of care, not placebo.

Let's do the real studies and then we'll talk and I'll consider using something that's so many multiples the cost of a pretty darn good current therapy.

 

[Southpaw]

The drug works period. I highly recommend it to control pain beyond 30 hours. I'd recommend it for my family members or myself.

You’re not answering @Mman. No one,
not a single poster here, disputes that exparel works. Almost every respectable anesthesiologist that I know at this point,
feels that exparel is NOT worth the cost when compared to bupiv + dex. Since many people likely read these posts but don’t respond (lurkers) I think it’s pretty irresponsible of you to continue touting exparel when it’s clear to almost everyone it’s no better than bupiv + dex, with cost taken into consideration.

 

[BLADEMDA]

You’re not answering @Mman. No one,
not a single poster here, disputes that exparel works. Almost every respectable anesthesiologist that I know at this point,
feels that exparel is NOT worth the cost when compared to bupiv + dex. Since many people likely read these posts but don’t respond (lurkers) I think it’s pretty irresponsible of you to continue touting exparel when it’s clear to almost everyone it’s no better than bupiv + dex, with cost taken into consideration.

I disagree. Exparel is better than any of the cocktails like Bup plus Decadron. Is it worth $315 vs $8 for the extra 10-18 hours? I think it is worth the cost considering the overall expense of an operation in the USA. Again, I highly recommend Exparel for friends and family as it is the best local anesthetic for duration of postop analgesia on the market.

 

[BLADEMDA]

That's great. Bupi and dex works great too.

I'm with @Mman. Placebo controlled trial is a joke, and in fact, it's part of the FDA reasoning to deny approval for PNB at this time.

Pacira is CLEARLY afraid exparel is really no better than bupi (and forget about bupi/dex) or else they would compare it to current standard of care, not placebo.

Let's do the real studies and then we'll talk and I'll consider using something that's so many multiples the cost of a pretty darn good current therapy.

Current standard of Bup with decadron and precedex is pretty good. Exparel is slightly better. The cost of many operations exceed $15k in the USA. Adding a $315 local anesthetic with a good safety profile and slightly longer duration of analgesia is worth it in my option.

I do agree large Clinical trials are needed to prove the efficacy of exparel vs our current standard of care That said, my experience with Exparel shows excellent safety data and reliable efficacy over 40 hours of postop analgesia.

 

[Southpaw]

I disagree. Exparel is better than any of the cocktails like Bup plus Decadron. Is it worth $315 vs $8 for the extra 10-18 hours? I think it is worth the cost considering the overall expense of an operation in the USA. Again, I highly recommend Exparel for friends and family as it is the best local anesthetic for duration of postop analgesia on the market.

I don’t believe exparel to be as reliable as bupi + dex. I also don’t see the benefit of a few more hours, if it’s true, when the patient is home with minimal pain and ready for their extremity to wake up.

 

[Arch Guillotti]

I disagree. Exparel is better than any of the cocktails like Bup plus Decadron. Is it worth $315 vs $8 for the extra 10-18 hours? I think it is worth the cost considering the overall expense of an operation in the USA. Again, I highly recommend Exparel for friends and family as it is the best local anesthetic for duration of postop analgesia on the market.

 

[Mman]

I disagree. Exparel is better than any of the cocktails like Bup plus Decadron. Is it worth $315 vs $8 for the extra 10-18 hours? I think it is worth the cost considering the overall expense of an operation in the USA. Again, I highly recommend Exparel for friends and family as it is the best local anesthetic for duration of postop analgesia on the market.

It's unfortunate all Pacira's trials that attempted to show it was better failed and were stopped early. They have tried to get a study to show the benefit, they just haven't been able to yet.

 

[facted]

Exparel is slightly better.

I do agree large Clinical trials are needed to prove the efficacy of exparel vs our current standard of care That said, my experience with Exparel shows excellent safety data and reliable efficacy over 40 hours of postop analgesia.

Prove that exparel is CLINICALLY SIGNIFICANTLY better in an RCT, and we'll talk. Until then, I think using Exparel for a PNB is indicated only if you own stock in Pacira.

 

[Tuohy]

Agree-everyone on here touting anecdotal evidence is absolutely ridiculous-like others have posted, they need to do an RCT (gold standard)-for now, I will stick with my 30 ml vial of bupi which costs $1.84; if you add PF dexamethasone, that is another $5-as compared to at least $300 for Exparel.

 

[BLADEMDA]

Agree-everyone on here touting anecdotal evidence is absolutely ridiculous-like others have posted, they need to do an RCT (gold standard)-for now, I will stick with my 30 ml vial of bupi which costs $1.84; if you add PF dexamethasone, that is another $5-as compared to at least $300 for Exparel.

The thousands of patients who have received TAP blocks, adductor canal blocks and paravertebral blocks over the past few years are all the proof I need the drug works quite well. Pain relief is in the 40-48 hour range and worth the $315. Unless you have actually used this drug more than a few times the comments posted are simply baseless and without much merit
I found it ridiculous that the haters of exparel have never actually used the drug or talked to patients who have been the recipient of nerve blocks with exparel. This stuff works and has a role in clinical practice.

Assuming my posts are accurate and truthful (which they are) exparel is $315 per vial so the cost should play in a role in deciding whether to use it or the standard cocktail of bupivacaine plus adjuvants. But, to dismiss exparel as ineffective and worthless is simply disingenuous.

 

[pgg]

Blade, no one is dismissing Exparel as ineffective. Where are you getting that?

 

[facted]

The thousands of patients who have received TAP blocks, adductor canal blocks and paravertebral blocks over the past few years are all the proof I need the drug works quite well. Pain relief is in the 40-48 hour range and worth the $315. Unless you have actually used this drug more than a few times the comments posted are simply baseless and without much merit
I found it ridiculous that the haters of exparel have never actually used the drug or talked to patients who have been the recipient of nerve blocks with exparel. This stuff works and has a role in clinical practice.

Assuming my posts are accurate and truthful (which they are) exparel is $315 per vial so the cost should play in a role in deciding whether to use it or the standard cocktail of bupivacaine plus adjuvants. But, to dismiss exparel as ineffective and worthless is simply disingenuous.

Exparel works. Of course it does!!!
It's a local anesthetic!

Does it work better than bupi/dex?!? If so, prove it. RCT or bust. Otherwise, this is a dumb conversation (and FDA sub-committee agrees).

 

[Mman]

The thousands of patients who have received TAP blocks, adductor canal blocks and paravertebral blocks over the past few years are all the proof I need the drug works quite well. Pain relief is in the 40-48 hour range and worth the $315. Unless you have actually used this drug more than a few times the comments posted are simply baseless and without much merit
I found it ridiculous that the haters of exparel have never actually used the drug or talked to patients who have been the recipient of nerve blocks with exparel. This stuff works and has a role in clinical practice.

Assuming my posts are accurate and truthful (which they are) exparel is $315 per vial so the cost should play in a role in deciding whether to use it or the standard cocktail of bupivacaine plus adjuvants. But, to dismiss exparel as ineffective and worthless is simply disingenuous.

local anesthetics work great. One of the wonders of the modern periop world is what we are able to do with them. I just don't think Exparel has been shown to be superior to current offerings with peripheral nerve blocks. Local infiltration in a wound? TAP block? Sure, you can find some evidence. Something like a femoral or interscalene nerve block? Nope.

 

[BLADEMDA]

Am J Surg. 2016 Sep;212(3):399-405. doi: 10.1016/j.amjsurg.2015.12.026. Epub 2016 Apr 12.
Efficacy of transversus abdominis plane block with liposomal bupivacaine during open abdominal wall reconstruction.
Fayezizadeh M1, Majumder A1, Neupane R1, Elliott HL1, Novitsky YW2.
Author information

Abstract
BACKGROUND:
Transversus abdominis plane block (TAPb) is an analgesic adjunct used for abdominal surgical procedures. Liposomal bupivacaine (LB) demonstrates prolonged analgesic effects, up to 72 hours. We evaluated the analgesic efficacy of TAPb using LB for patients undergoing open abdominal wall reconstruction (AWR).

METHODS:
Fifty patients undergoing AWR with TAPb using LB (TAP-group) were compared with a matched historical cohort undergoing AWR without TAPb (control group). Outcome measures included postoperative utilization of morphine equivalents, numerical rating scale pain scores, time to oral narcotics, and length of stay (LOS).

RESULTS:
Cohorts were matched demographically. No complications were associated with TAPb or LB. TAP-group evidenced significantly reduced narcotic requirements on operative day (9.5 mg vs 16.5 mg, P = .004), postoperative day (POD) 1 (26.7 mg vs 39.5 mg, P = .01) and POD2 (29.6 mg vs 40.7 mg, P = .047) and pain scores on operative day (5.1 vs 7.0, P <.001), POD1 (4.2 vs 5.5, P = .002), and POD2 (3.9 vs 4.8, P = .04). In addition, TAP-group demonstrated significantly shorter time to oral narcotics (2.7 days vs 4.0 days, P <.001) and median LOS (5.2 days vs 6.8 days, P = .004).

CONCLUSIONS:
TAPb with LB demonstrated significant reductions in narcotic consumption and improved pain control. TAPb allowed for earlier discontinuation of intravenous narcotics and shorter LOS. Intraoperative TAPb with LB appears to be an effective adjunct for perioperative analgesia in patients undergoing open AWR.

 

[BLADEMDA]

Plast Reconstr Surg. 2017 Aug;140(2):240-251. doi: 10.1097/PRS.0000000000003508.
Transversus Abdominis Plane Blocks with Single-Dose Liposomal Bupivacaine in Conjunction with a Nonnarcotic Pain Regimen Help Reduce Length of Stay following Abdominally Based Microsurgical Breast Reconstruction.
Jablonka EM1, Lamelas AM, Kim JN, Molina B, Molina N, Okwali M, Samson W, Sultan MR, Dayan JH, Smith ML.
Author information

Abstract
BACKGROUND:
Side effects associated with use of postoperative narcotics for pain control can delay recovery after abdominally based microsurgical breast reconstruction. The authors evaluated a nonnarcotic pain control regimen in conjunction with bilateral transversus abdominis plane blocks on facilitating early hospital discharge.

METHODS:
A retrospective analysis was performed of consecutive patients who underwent breast reconstruction using abdominally based free flaps, with or without being included in a nonnarcotic protocol using intraoperative transversus abdominis plane blockade. During this period, the use of locoregional analgesia evolved from none (control), to continuous bupivacaine infusion transversus abdominis plane and catheters, to single-dose transversus abdominis plane blockade with liposomal bupivacaine solution. Demographic factors, length of stay, inpatient opioid consumption, and complications were reported for all three groups.

RESULTS:
One hundred twenty-eight consecutive patients (182 flaps) were identified. Forty patients (62 flaps) were in the infusion-liposomal bupivacaine group, 48 (66 flaps) were in the single-dose blockade-catheter group, and 40 (54 flaps) were in the control group. The infusion-liposomal bupivacaine patients had a significantly shorter hospital stay compared with the single-dose blockade-catheter group (2.65 ± 0.66 versus 3.52 ± 0.92 days; p < 0.0001) and the control group (2.65 ± 0.66 versus 4.05 ± 1.26 days; p < 0.0001). There was no significant difference in flap loss or major complications among groups.

CONCLUSIONS:
When used as part of a nonnarcotic postoperative pain regimen, transversus abdominis plane blocks performed with single injections of liposomal bupivacaine help facilitate early hospital discharge after abdominally based microsurgical breast reconstruction. A trend toward consistent discharge by postoperative day 2 was seen. This could result in significant cost savings for health care systems.

 

[BLADEMDA]

Overall, patients in the TAP block group used little narcotics. Within 24 hours, only 1 patient used tables of oxycodone (5 mg)/acetaminophen (325 mg). On postoperative day 3, 72 hour after the TAP block, an additional patient requested and received 5 mgs of oxycodone with 325 mgs of acetaminophen 3 times. Additional, a third patient was transferred to the cardiac ICU for continuous monitoring since she had postpartum cardiomyopathy after her last pregnancy. She received tables of oxycodone (5 mg)/acetaminophen (325 mg) every day for anticipated pain (even through her report pains were 0). These results demonstrate that post Cesarean section patients receiving the TAP blocks with liposomal bupivacaine had significant postoperative pain relief (Table 2) and used little postoperative narcotic. Patient satisfaction scores were 9.3 ± 1.1 (mean ± SD) (Table 3) on an 11 point scale

https://file.scirp.org/pdf/OJAnes_2017122715563572.pdf

 

[BLADEMDA]

We present 5 cases of women requiring bilateral
mastectomy for breast cancer; all included immediate
reconstruction involving bilateral tissue expander
placement. Our course for postsurgical pain control
included ultrasound guided single shot tPVBs performed
at the T4 level using liposomal bupivacaine. We found
that this technique provided extended post-operative
pain control, lowered narcotic use, improved pain
scores and resulted in no incidence of postoperative
nausea or vomiting. Additionally, two cases were able
to be discharged home on POD 1. These cases
demonstrate a new approach to an old technique that
can help breast cancer patients with their recovery by
effectively managing their postoperative pain

Single shot T4 Level Paravertebral Block with liposomal bupivacaine in mastectomy with breast reconstruction | 41st Annual Regional Anesthesiology and Acute Pain Medicine Meeting, 2016

 

[BLADEMDA]

Agree-everyone on here touting anecdotal evidence is absolutely ridiculous-like others have posted, they need to do an RCT (gold standard)-for now, I will stick with my 30 ml vial of bupi which costs $1.84; if you add PF dexamethasone, that is another $5-as compared to at least $300 for Exparel.

Just a small advantage for a few patients can skew the costs in favor of Liposomal Bupivacaine. It's $315 but the total cost is over $20,000:

Ann Pharmacother. 2016 Mar;50(3):194-202. doi: 10.1177/1060028015626161. Epub 2016 Jan 18.
Adductor Canal Block With Bupivacaine Liposome Versus Ropivacaine Pain Ball for Pain Control in Total Knee Arthroplasty: A Retrospective Cohort Study.
Wang Y1, Klein MS2, Mathis S2, Fahim G3.
Author information

Abstract
BACKGROUND:
Appropriate postoperative pain control following total knee arthroplasty is important in patient recovery. Adductor canal block (ACB) is a novel method to deliver anesthesia. There are currently no studies using bupivacaine liposome with ACB while also taking into account cost.

OBJECTIVE:
To compare the efficacy and cost of using bupivacaine liposome to ropivacaine pain ball (RPB) for postsurgical pain control in total knee replacement surgery. The primary efficacy endpoint is mean pain score. Secondary endpoints include opioid and nonopioid pain medication consumption and cost per patient case.

METHODS:
This was a retrospective, matched cohort study with data collected from electronic medical records from February 2013 to June 2014. Mean pain score was measured by the 11-point Visual Analogue Scale over a 72-hour period. Cost analysis was also done looking at medication, direct, indirect, and total cost per patient case.

RESULTS:
Mean pain score over the 72 hours was 3.24 in the bupivacaine liposome group compared with 3.83 in the RPB group (P < 0.001). Lower mean pain scores were found in the bupivacaine liposome group during the first 36-hour interval postsurgery (3.1 vs 4.0, respectively, P < 0.001). Mean total cost was $20,919.53 with bupivacaine liposome versus $22,574.17 with RPB (P = 0.03).

CONCLUSION:
Liposomal bupivacaine demonstrated statistically significant impact in pain control in the first 36 hours, but by the end of the 72-hour interval, it was comparable to RPB in postoperative pain management. Using bupivacaine liposome did provide direct and total cost savings compared with RPB.

 

[BLADEMDA]

It has been postulated that liposomal bupivacaine may obviate the need for continuous perineural infusions Recent studies suggest non-inferiority between adductor canal catheters and femoral catheters. Our group has recently attempted the use of liposomal bupivacine within the adductor canal as a replacement for femoral nerve catheters following total knee arthroplasty. While pain scores within the first 24 hours were less in patients receiving femoral catheters, patients who received liposomal bupivacaine adductor canal blocks performed just as well on postoperative days one and two in regards to pain scores and opioid use. The difference seen in pain scores in the PACU and post-op day zero may speak more differences in block efficacy than the efficacy of liposomal bupivacaine.

Adductor Canal Blocks using Liposomal Bupivacaine versus ... | SLIDEBLAST.COM

 

[facted]

Am J Surg. 2016 Sep;212(3):399-405. doi: 10.1016/j.amjsurg.2015.12.026. Epub 2016 Apr 12.
Efficacy of transversus abdominis plane block with liposomal bupivacaine during open abdominal wall reconstruction.
Fayezizadeh M1, Majumder A1, Neupane R1, Elliott HL1, Novitsky YW2.
Author information

Abstract
BACKGROUND:
Transversus abdominis plane block (TAPb) is an analgesic adjunct used for abdominal surgical procedures. Liposomal bupivacaine (LB) demonstrates prolonged analgesic effects, up to 72 hours. We evaluated the analgesic efficacy of TAPb using LB for patients undergoing open abdominal wall reconstruction (AWR).

METHODS:
Fifty patients undergoing AWR with TAPb using LB (TAP-group) were compared with a matched historical cohort undergoing AWR without TAPb (control group). Outcome measures included postoperative utilization of morphine equivalents, numerical rating scale pain scores, time to oral narcotics, and length of stay (LOS).

RESULTS:
Cohorts were matched demographically. No complications were associated with TAPb or LB. TAP-group evidenced significantly reduced narcotic requirements on operative day (9.5 mg vs 16.5 mg, P = .004), postoperative day (POD) 1 (26.7 mg vs 39.5 mg, P = .01) and POD2 (29.6 mg vs 40.7 mg, P = .047) and pain scores on operative day (5.1 vs 7.0, P <.001), POD1 (4.2 vs 5.5, P = .002), and POD2 (3.9 vs 4.8, P = .04). In addition, TAP-group demonstrated significantly shorter time to oral narcotics (2.7 days vs 4.0 days, P <.001) and median LOS (5.2 days vs 6.8 days, P = .004).

CONCLUSIONS:
TAPb with LB demonstrated significant reductions in narcotic consumption and improved pain control. TAPb allowed for earlier discontinuation of intravenous narcotics and shorter LOS. Intraoperative TAPb with LB appears to be an effective adjunct for perioperative analgesia in patients undergoing open AWR.

So I'm other words, TAP blocks work? Thanks. Kinda knew that. Your post of this is total misdirection.

Again, please show us some evidence that exparel is better than bupi/dex for blocks, not that exparel is a local anesthetic.

 

[facted]

We present 5 cases of women requiring bilateral
mastectomy for breast cancer; all included immediate
reconstruction involving bilateral tissue expander
placement. Our course for postsurgical pain control
included ultrasound guided single shot tPVBs performed
at the T4 level using liposomal bupivacaine. We found
that this technique provided extended post-operative
pain control, lowered narcotic use, improved pain
scores and resulted in no incidence of postoperative
nausea or vomiting. Additionally, two cases were able
to be discharged home on POD 1. These cases
demonstrate a new approach to an old technique that
can help breast cancer patients with their recovery by
effectively managing their postoperative pain

Single shot T4 Level Paravertebral Block with liposomal bupivacaine in mastectomy with breast reconstruction | 41st Annual Regional Anesthesiology and Acute Pain Medicine Meeting, 2016

Sorry to burst your bubble, but IMO injecting exparel neuraxially is malpractice. Go ahead and do TAP blocks all day with it, but PVB?!? Call me old-fashioned but that's crazy. Absolutely no safety data for it in this application.

Would you put in an epidural?

 

[caligas]

Not sure when to try to catch this falling knife (or falling turd?).

 

[BLADEMDA]

APRIL 7, 2018
FDA Approves Liposomal Bupivacaine for Interscalene Brachial Plexus Block



On Friday, April 6, the FDA approved a supplemental new drug application (sNDA) for the administration of liposomal bupivacaine (Exparel, Pacira) via interscalene brachial plexus block for postoperative regional analgesia.

Liposomal bupivacaine now becomes the first long-acting, single-dose nerve block available for upper extremity surgeries, such as total shoulder arthroplasty.

The approval comes despite an earlier, marginally negative vote by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, which voted on February 15 (6-4 against) to not recommend the sNDA for approval. The fact that liposomal bupivacaine is a non-opioid alternative for post-op pain certainly would have improved the odds for approval.

 

[BLADEMDA]

Sorry to burst your bubble, but IMO injecting exparel neuraxially is malpractice. Go ahead and do TAP blocks all day with it, but PVB?!? Call me old-fashioned but that's crazy. Absolutely no safety data for it in this application.

Would you put in an epidural?

Exparel is now FDA approved for nerve blocks. I expect usage will double over the next 12 months.

 

[caligas]

While I agree that we still need to see a real head to head trial, I feel like this is not a bad entry point for this one in my mad money/speculative account, which totals about 5% of my portfolio.

 

[facted]

Exparel is now FDA approved for nerve blocks. I expect usage will double over the next 12 months.

Actually, only for interscalene block, and that appears to be based on one study which didn't find a longer duration of action or even decreased opiod consumption for the treatment group.

Certainty more people will use it and when the data comes out comparing to current standard of care (0.5% bupi and decardon), it will go out of favor as it already is for total joint infiltration.

Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shou... - PubMed - NCBI

 

[Southpaw]

come on, really? one study that looked at liposomal bupivacaine vs placebo after 48 hours. The study and the approval based on it tells me nothing. Due to cost, and the fact that I've repeatedly stated that most patients do not want a motor block lasting > 24 hours, I'll continue to use bupiv + dex.

 

[caligas]

come on, really? one study that looked at liposomal bupivacaine vs placebo after 48 hours. The study and the approval based on it tells me nothing. Due to cost, and the fact that I've repeatedly stated that most patients do not want a motor block lasting > 24 hours, I'll continue to use bupiv + dex.

IF they can prove improved duration, what about as a substitute for nerve block catheters?

 

[pgg]

I did a VATS pleurodesis the other day in a guy who'd received a serratus plane block with Exparel two days previously. Package insert says no local for 96 hours.

Felt a little constrained in our options. Usually that surgeon does intercostals with ropivacaine or Exparel. Could have done an opioid only thoracic epidural I guess. Ultimately he got nothing.

He didn't get much relief from the from the serratus block past the first day.

I was never really impressed with Exparel but I'm even less so now.

 

[Noyac]

Does this trouble anyone:
“Indeed, the FDA's announcement stressed that the FDA had declined to approve "general use of Exparel for regional nerve blocks for post-surgical analgesia other than shoulder surgery," finding the clinical data insufficient.

In February, an FDA advisory committee split on whether to recommend the approval, with only four of 10 members voting in favor. Among the concerns were excess deaths among patients receiving the drug.

Committee members recommended follow-up studies. However, the FDA announcement made no mention of requiring post-marketing studies.”

Exparel Gets OK for Expanded Indication

 

[facted]

Does this trouble anyone:
“Indeed, the FDA's announcement stressed that the FDA had declined to approve "general use of Exparel for regional nerve blocks for post-surgical analgesia other than shoulder surgery," finding the clinical data insufficient.

In February, an FDA advisory committee split on whether to recommend the approval, with only four of 10 members voting in favor. Among the concerns were excess deaths among patients receiving the drug.

Committee members recommended follow-up studies. However, the FDA announcement made no mention of requiring post-marketing studies.”

Exparel Gets OK for Expanded Indication

All of exparel troubles me. There's SUCH little evidence for it vs common therapy and people flock to it because some marketing that it lasts 3 days, which is not demonstrated in most studies.

It's great marketing, and not much else.

 

[Ronin786]

I'm glad there's still some common sense out there with anesthesiologists in relation to Exparel. I think the smartest thing Pacira did was market Exparel to surgeons, making most of them believe that their local infiltration and "blocks" were keeping their patients pain free for 72 hours post-op.

They all flock to use it everywhere and the patient ends up without any regional solution for their pain for the next 4 days.

 

[BLADEMDA]

Like many things the truth lies somewhere in the middle of this conversation:

1. Exparel works- it's a local anesthetic that when diluted has an efficacy in the 24-48 hour range. If diluted up to 80 mls the duration diminishes to 24 hours. I rarely, if ever, see postop pain relief beyond 48 hours.

2. Now that it is FDA approved more studies will be done comparing it to the current standard. This is a good thing for patients and Anesthesiologists.

3. Exparel is not meant to replace the current standard of practice. It is another local anesthetic now available for around $315 for a certain subgroup of patients. Some Anesthesiologists will use it a lot while others refuse to even give it a try.

4. The benefits of Exparel exceed the cost in certain situations and I recommend it over catheters/pumps for patients. Examples of blocks I like to use it include Pecs1 and 2, Serratus Anterior, TAP, and ESP.

5. If a patient needed a second surgery after a block with Exparel (more than 24 hours) I would re-block the patient with additional local anesthetic if it was a field type block (TAP, Serratus, Pecs, ESP, etc)

 

[Noyac]

Like many things the truth lies somewhere in the middle of this conversation:

1. Exparel works- it's a local anesthetic that when diluted has an efficacy in the 24-48 hour range. If diluted up to 80 mls the duration diminishes to 24 hours. I rarely, if ever, see postop pain relief beyond 48 hours.

2. Now that it is FDA approved more studies will be done comparing it to the current standard. This is a good thing for patients and Anesthesiologists.

3. Exparel is not meant to replace the current standard of practice. It is another local anesthetic now available for around $315 for a certain subgroup of patients. Some Anesthesiologists will use it a lot while others refuse to even give it a try.

4. The benefits of Exparel exceed the cost in certain situations and I recommend it over catheters/pumps for patients. Examples of blocks I like to use it include Pecs1 and 2, Serratus Anterior, TAP, and ESP.

5. If a patient needed a second surgery after a block with Exparel (more than 24 hours) I would re-block the patient with additional local anesthetic if it was a field type block (TAP, Serratus, Pecs, ESP, etc)

I appreciate your POV on this Blade but something tells me we have a very different pt population. I rarely find the need for the blocks you just listed. I guess I could do the PEC and Serratus more often on breast cases but those pts of mine just are not that uncomfortable. Occasionally, I find the need for the TAP block.
But I’d like to know more about the “deaths” that the FDA was worried about the first time they reviewed Exparel.

 

[epidural man]

But I’d like to know more about the “deaths” that the FDA was worried about the first time they reviewed Exparel.

Holy crap me too! I didn't know there where deaths. I wonder why.

 

[epidural man]

I did a VATS pleurodesis the other day in a guy who'd received a serratus plane block with Exparel two days previously. Package insert says no local for 96 hours.

Felt a little constrained in our options. Usually that surgeon does intercostals with ropivacaine or Exparel. Could have done an opioid only thoracic epidural I guess. Ultimately he got nothing.

He didn't get much relief from the from the serratus block past the first day.

I was never really impressed with Exparel but I'm even less so now.

We have placed epidurals after failed exparel tap blocks. The folks that did it published the case report with serum data.

We have to show pharmacy this study every time because they are resistant, but after seeing the serum data, they let us run the local.

 

[Noyac]

Current standard of Bup with decadron and precedex is pretty good. Exparel is slightly better. The cost of many operations exceed $15k in the USA. Adding a $315 local anesthetic with a good safety profile and slightly longer duration of analgesia is worth it in my option.

I do agree large Clinical trials are needed to prove the efficacy of exparel vs our current standard of care That said, my experience with Exparel shows excellent safety data and reliable efficacy over 40 hours of postop analgesia.

The FDA Denied Exparel less than a year ago due “DEATHS”.

 

[Noyac]

If anyone wants to know how Exparel all of a sufpdden got past the FDA then read this:
The Corruption of Evidence Based Medicine — Killing for Profit

Follow the money.

 

[Noyac]

And another thing, you can’t compare it to placebo. That’s ludicrous. What happened is that they did compare it to bupivicaine and it didn’t fair any better. So when a study doesn’t make sense then you need to think about it. Why doesn’t it make sense, well because it’s the only one that showed any benefit. And these studies are all funded by big pharma.

I also don’t care that the pts took more narcs in the placebo group. No **** Sherlock. It was saline. I want to know, when the block wore off whether it was one day two days or three days, how much narcs did they take post block day1-7. That’s what matters. Just because they took narcs a day early really doesn’t matter to me.

Everyone should be extremely cautious with this product and this company. I have a rep coming to sell this to us next week. I doubt many or any of us show up, not even the hungry ones.

 

[epidural man]

And another thing, you can’t compare it to placebo. That’s ludicrous. What happened is that they did compare it to bupivicaine and it didn’t fair any better. So when a study doesn’t make sense then you need to think about it. Why doesn’t it make sense, well because it’s the only one that showed any benefit. And these studies are all funded by big pharma.

I also don’t care that the pts took more narcs in the placebo group. No **** Sherlock. It was saline. I want to know, when the block wore off whether it was one day two days or three days, how much narcs did they take post block day1-7. That’s what matters. Just because they took narcs a day early really doesn’t matter to me.

Everyone should be extremely cautious with this product and this company. I have a rep coming to sell this to us next week. I doubt many or any of us show up, not even the hungry ones.

Noyac,

I would guess that the FDA MADE them compare it to placebo.

I agree with you - the FDA is super corrupt, so I'm not saying there isn't foul play.

But Pacira is not "big pharma"....they are up against MUCH BIGGER fish, and the real question is why it took them so long to get approved - and if you ask me...follow the money on that and I bet it would tell a different story. The FDA has screwed Pacira at every turn and I assume it is because of BIG PHARMA that has much deeper pockets that have a LOT to loose if PACIRA succeeds.

I'm not sure why you have such disdain for this product. Maybe it doesn't work as well as straight bupivicaine - but you have to admit...it's a pretty good and cool college try and idea what they are going for.

 

[pgg]

Noyac,

I would guess that the FDA MADE them compare it to placebo.

You really think they haven't compared it to bupivacaine?

Publication bias is real.

I'm not sure why you have such disdain for this product. Maybe it doesn't work as well as straight bupivicaine - but you have to admit...it's a pretty good and cool college try and idea what they are going for.

I don't doubt that they're a bunch of swell guys with neat ideas trying really hard with good intentions, but why would you let their hopes and dreams influence the risk & cost benefit decisions you make?


Do you remember DepoDur (liposomal morphine)? It was an exciting fad for a couple years until the enthusiasts couldn't spin the uninspiring studies any longer. I'm pretty sure it was better than placebo too.

Guess which company was behind DepoDur ... go on, guess.

 

[dhb]

Why not just try it and make your own opinion? I would love to be able to try it out.
If it works well and the patient doesn't have to pay out of pocket great.
If it's not better then back to good old bupivacaine.

 

[epidural man]

You really think they haven't compared it to bupivacaine?

Publication bias is real.




I don't doubt that they're a bunch of swell guys with neat ideas trying really hard with good intentions, but why would you let their hopes and dreams influence the risk & cost benefit decisions you make?


Do you remember DepoDur (liposomal morphine)? It was an exciting fad for a couple years until the enthusiasts couldn't spin the uninspiring studies any longer. I'm pretty sure it was better than placebo too.

Guess which company was behind DepoDur ... go on, guess.

Pgg - my point is...to get an IND approval, I suspect you have to study it against placebo for an FDA approval. People are implying that Pacira compared it against placebo because they new it would work and they DIDNT do it against bulivicaine because they felt like it wouldn’t work better.

To get a new drug indication, you have to show it works. Even if they did show a superiority study against bupiviciane, I suspect the FDA would not approve because it wasn’t against placebo. First things first. They FIRST need FDA to give them the indication. That is what they did.

Next, my decision to use it has to do with available evidence and personal experience. What I don’t understand is the apparent hostility towards the company and drug.

 

[pgg]

I was supposing that they probably do have data on Exparel vs bupivacaine and the reason we haven't seen it is because it's not flattering to Exparel ... i.e. publication bias.

 

[BLADEMDA]

I was supposing that they probably do have data on Exparel vs bupivacaine and the reason we haven't seen it is because it's not flattering to Exparel ... i.e. publication bias.

IMHO, Exparel is FDA approved for ISB and thus, other Plexus blocks. Unlike other "adjuvants" Exparel is safe and will provide analgesia well beyond 24 hours. For those who think perineural dexamethasone is perfectly safe and without added risk I urge you to read my next post.