turnupthevapor

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Anyone know why the 0.5% bupi bottles say "not for spinal". Always makes me a touch uneasy as I am drawing it up for my TKA's each day!

I am assuming they never got it approved by the fda for spinals but i am wondering if the story is deeper and if there are any legal implications.

While were on the subject how much do you use?

for me big dude 3.5 w .2 morphine
small lady 2.5 cc no morphine

I know some of the guys in my group use 20 mg and state that the level doesnt really change just increased duration.

what do all you think?


thanks:oops:
 

maceo

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Anyone know why the 0.5% bupi bottles say "not for spinal". Always makes me a touch uneasy as I am drawing it up for my TKA's each day!

I am assuming they never got it approved by the fda for spinals but i am wondering if the story is deeper and if there are any legal implications.

While were on the subject how much do you use?

for me big dude 3.5 w .2 morphine
small lady 2.5 cc no morphine

I know some of the guys in my group use 20 mg and state that the level doesnt really change just increased duration.

what do all you think?


thanks:oops:
my first spinal as an attending was a guy who had a ef of like 20 percent. I forget the procedure but one of the other guys handed me a bottle of .5 percent marcaine and said use this. I was kind of rushed for time, so i hurriedly drew up 2 cc of the stuff and gave it. The hopes was that it would not cause that much of a sympathectomy. it worked like a charm. Than i read the bottle and it said not for spinal. I said oh well. never used it again in that fashion. no negative seequelae
 
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Lonestar

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Our group uses 0.5% bupiv all the time for total hips and Total knees. We also use 0.25 mg Astromorph. Our group has been using this for a long long time and have wonderful results. Pts complain of less post-op pain and the orthopods like it b/c it helps their pts with postop physical therapy. Overall, just better results with Astromorph. With the bupivicaine, we usually don't intubate our pts, rather use propofol infusion with nasal cannula.

I have done quit a few already and haven't had much issues except for pruritis and occasional nausea post-op.
 

Arch Guillotti

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my first spinal as an attending was a guy who had a ef of like 20 percent. I forget the procedure but one of the other guys handed me a bottle of .5 percent marcaine and said use this. I was kind of rushed for time, so i hurriedly drew up 2 cc of the stuff and gave it. The hopes was that it would not cause that much of a sympathectomy. it worked like a charm. Than i read the bottle and it said not for spinal. I said oh well. never used it again in that fashion. no negative seequelae


So you don't use .5% bupi for spinals at all now?
 

Bertelman

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More than a few of our attendings get a rise out of CA-1s by getting them to use the .5%, then after the spinal's in, dropping their jaw and saying- WHAT DID YOU USE THIS FOR!!!

Always good for a laugh.
 

pgg

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Anyone know why the 0.5% bupi bottles say "not for spinal".
Because it's a multidose vial. You shouldn't take a vial that's already open and use it for neuraxial anesthesia.

No big deal and perfectly OK to use if you crack it open and draw up your dose.
 

Noyac

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my first spinal as an attending was a guy who had a ef of like 20 percent. I forget the procedure but one of the other guys handed me a bottle of .5 percent marcaine and said use this. I was kind of rushed for time, so i hurriedly drew up 2 cc of the stuff and gave it. The hopes was that it would not cause that much of a sympathectomy. it worked like a charm. Than i read the bottle and it said not for spinal. I said oh well. never used it again in that fashion. no negative seequelae
It is well known that 0.5% bupiv is safe for spinals. I thought everyone knew this.
 

coprolalia

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Because it's a multidose vial. You shouldn't take a vial that's already open and use it for neuraxial anesthesia.

No big deal and perfectly OK to use if you crack it open and draw up your dose.
Huh?

:confused:

Local anaesthetic solutions containing antimicrobial preservatives, i.e., those supplied in multiple dose vials, should not be used for epidural or caudal anaesthesia because safety has not been established with regard to intrathecal injection, either intentional or unintentional, of such preservatives.
http://www.health.gov.il/units/pharmacy/trufot/alonim/1268.pdf

The stuff that is labeled "not for spinal use" contains a preservative. The warning has nothing to do with it being a multi-use vial, except for the fact that because it's multi-use it contains a preservative.

-copro
 

Noyac

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The one I'm familiar with says single use only.

It's been a long time since I've looked at this but I don't think its for the perservatives. I need to look at the bottle again. I don't use it.
 

bubalus

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We've got preservative free 0.5% in single dose vials that says not for spinal.
 

coprolalia

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I am going to specifically look today. I will even take a picture, if necessary.

The 0.75% Marcaine in dextrose in the 2mL vial clearly is for spinal, and is marked as such. It is preservative free.

The 10mL vials we have of Sensorcaine (with the peel-away rubber tops) that come in either 0.5% or 0.25% and say "not for spinal", at least at our institution, have preservative in them (IIRC). These are meant, if I understand the manufacturer, only to be used in field blocks, skin infiltration, etc. These are not even intented to be put in epidurals, if you read the detailed labeling to the letter.

Do we do this anyway? All the time. Would we (potentially) fry in court if some lawyer pulled out the packaging if something went wrong? That's up to the jury. Of course, that is not a reason to do or not do something. It's just a reality.

-copro
 

Planktonmd

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I am going to specifically look today. I will even take a picture, if necessary.

The 0.75% Marcaine in dextrose in the 2mL vial clearly is for spinal, and is marked as such. It is preservative free.

The 10mL vials we have of Sensorcaine (with the peel-away rubber tops) that come in either 0.5% or 0.25% and say "not for spinal", at least at our institution, have preservative in them (IIRC). These are meant, if I understand the manufacturer, only to be used in field blocks, skin infiltration, etc. These are not even intented to be put in epidurals, if you read the detailed labeling to the letter.

Do we do this anyway? All the time. Would we (potentially) fry in court if some lawyer pulled out the packaging if something went wrong? That's up to the jury. Of course, that is not a reason to do or not do something. It's just a reality.

-copro
There are vials of Bupivacaine 0.25, 0.50, 0.75 that are preservative free but are marked not for spinal.
These are usually the ones you use for epidural anesthesia and it is clearly stated on the bottle that they are OK for epidural anesthesia, and these are OK to use in the spinal.
The ones with preservative do not mention epidural anesthesia and they are for field infiltration.
I thought you guys knew that.
 

SleepIsGood

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As people have mentioned above. Most of these "not for spinal' bottles are preservative free. We use these all the time for spinals however. I do not know the reasoning behind this. NO negative sequelae have occurred at our institution d/t this.
 

pgg

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Huh?

:confused:



http://www.health.gov.il/units/pharmacy/trufot/alonim/1268.pdf

The stuff that is labeled "not for spinal use" contains a preservative. The warning has nothing to do with it being a multi-use vial, except for the fact that because it's multi-use it contains a preservative.

-copro
We have 30 mL bottles of 0.5% bupivacaine, preservative free, marked not for spinal. I suppose these aren't true multi-dose vials.

The two most reasonable explanations I've heard for why they're marked not for spinal were "the manufacturer doesn't want to imply that 30 mL is ever an appropriate spinal dose" to "it's got a stoppered top designed to be punctured more than once, potentially resulting in contaminated 2nd aliquots, so it shouldn't go in the spine" ...
 

Planktonmd

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The two most reasonable explanations I've heard for why they're marked not for spinal were "the manufacturer doesn't want to imply that 30 mL is ever an appropriate spinal dose" to "it's got a stoppered top designed to be punctured more than once, potentially resulting in contaminated 2nd aliquots, so it shouldn't go in the spine" ...
Both explanations are correct:
This is a multi dose vial (contamination risk) and it has too much medicine in it.
:thumbup:
 

Hockeyguy

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More than a few of our attendings get a rise out of CA-1s by getting them to use the .5%, then after the spinal's in, dropping their jaw and saying- WHAT DID YOU USE THIS FOR!!!

Always good for a laugh.
One of my favorite attendings did that to me on before a section. He made me squirm for like two minute before busting out for like 20 mins. Anyway to his knowledge its says that because as someone else metioned it has been formally approved by FDA.
 

IceDoc

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What I really want to know is some 30cc vials of Mepivicaine we have say "Methylparaben Free", but they don't say "preservative free." The vial doesn't say that anything else is in there. Does this Mepivicaine have anything else in it? Just to be safe, I won't use it for spinal.

But the preservative free Bupivicaine 0.5% works wonders, I've had a dip in BP only once with it.
 

thegasman

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my understanding also is the not for spinal 0.5 bupiv preservative free (it says on the bottle for use in epidural, etc) is not for spinal because it has not been fda approved for this use and cannot be marketed as such. I had a few attendings in training that made a big deal of this and would not use it, although most others made fun of this. Those that would not use it were afraid of lawsuits. Lawyer says "so Dr, why did you give a drug that is not fda approved?" Fentanyl is not fda approved for spinal either although it too is used frequently, so I think the whole thing is silly.
 

penghill

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what do you use for spinal? we use it for lots years already in china.
 

Intubate

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my understanding also is the not for spinal 0.5 bupiv preservative free (it says on the bottle for use in epidural, etc) is not for spinal because it has not been fda approved for this use and cannot be marketed as such. I had a few attendings in training that made a big deal of this and would not use it, although most others made fun of this. Those that would not use it were afraid of lawsuits. Lawyer says "so Dr, why did you give a drug that is not fda approved?" Fentanyl is not fda approved for spinal either although it too is used frequently, so I think the whole thing is silly.
Right. This is just off label use of a medication which we do all the time. Very few things are approved to go IT. Any narcotic IT is off label. Fentanyl use in pediatrics is even off label. The isobaric bupivicaine is safe in a spinal.
 
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