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- Sep 27, '08 by paindocThe manufacturers never applied to the FDA for that usage. The common usage administered epidurally is so prevalent that the manufacturers elected not to spend the tens to hundreds of millions of dollars to have the FDA approve an already commonly employed practice.
- Sep 27, '08 by Happy Halothane[quote=paindoc;3134409]Actually, there is no evidence polyethylene or polypropylene glycol cause adhesive arachnoiditis, but there is speculation by those that have no proof of such. If you have proof, please present it here as it would fundamentally change the way we practice pain medicine. There is no absolute method of assuring some medication administered epidural or partially transdural would not cross over into the CSF, therefore all epidural injections containing any PEG would be contraindicated according to such thinking.
Fluoroscopy or not, intrathecal injection is still a very real risk when administering epidural treatments. I'm sure you inform every one of your patients of the slight risk of a wet tap, right?
There is no need to "fundamentally change the way we practice pain medicine." That seems a just a little perponderant, don't you think? Epidural injection can inadvertantly become intravascular or intrathecal. "It seems fluoroscopy guidance may not prevent intrathecal perforation or spinal cord penetration"(Tripathi. Anesth Analg 2005;101:1209-1211).
Injecting an alcohol into the CSF would be deleterious, would you not agree?
So what makes it acceptable to administer a drug via a route not approved by the FDA? Because its common practice...because everyone does it?
Is that how you would respond to an attorney during a trial?
Nelson DA. Arch Neurol. 1988 Jul;45(7):804-6.
"Dangers from methylprednisolone acetate therapy by intraspinal injection."
Section of Neurology in Medicine, Medical Center of Delaware, Wilmington.
"Clinical trials first began in 1960 with methylprednisolone acetate (Depo-Medrol) administered intrathecally, in an attempt to treat both disk disease and multiple sclerosis. After a few reports of salubrious results, there began an outpouring of contradictory data, which continues in 1988. During this time span, researchers who cautiously tested the different theses of improvement began to publish serious warnings of many complications. For ten years prior to the intraspinal use of methylprednisolone acetate, basic scientists in anesthesiology and neurochemistry had published the following facts:
(1) Methylprednisolone acetate's content of polyethylene glycol raises the risks of using it near the central nervous system.
(2) Deleterious effects follow the use of glycols when they are placed into or near the neuraxis.
(3) Methylprednisolone acetate contains approximately 30 mg of polyethylene glycol per milliliter.
(4) When that glycol, which is both alcohol and detergent, is injected intraspinally, sterile meningitis, arachnoiditis, or pachymeningitis will occur.
It has also been recognized since the 1960s that the epidural space is not wholly separate from the subdural and/or subarachnoid space. Many thousands of arachnoid villi subtend all the membranes from the intrathecal space, and many of these end in the large epidural veins. Therefore, the various spaces and membranes are not only contiguous, but continuous.
It follows that an injection of methylprednisolone acetate into the epidural space does not guarantee that it will remain isolated there.
Finally, the inadvertency of injections by the epidural route occurs with the following frequency: 40% of injections can be inadvertently made into interspinous ligaments, and 2.5% into the subarachnoid space.
- Sep 28, '08 by sewnewSorry, I did not intend for this to turn into a heated discussion. These questions are only coming from a nursing student who is an aspiring CRNA...
Nevertheless, Happy Halothane, you raise a very good point...
It seems to me that this study implies that the risks outweigh the benefits in using the aforementioned steroids in ESIs (and of course this process has to be done on an individualized basis depending on the condition of each patient). If this is the case, why have there not been any more recent studies to test this theory? The study you mentioned dates back to 1988. If this is such common practice, don't you think that health care providers who practice pain medicine would want more substantiated evidence about the efficacy of ESIs?
I guess what I am trying to say is, doesn't the modern medical model (and nursing model for that matter) follow the approach of utilizing evidence-based medicine? It seems that the practice of using ESIs does not have well documented evidence that they are effective.
Please correct me if I am wrong...
- Sep 28, '08 by Happy HalothaneIn all fairness, I selected the article to prove a point...for a discussion that can't be won. There have been countless studies on ESI since then, and the practice of ESI is commonplace--because of evidenced based medicine.
I helped evolve the original question into a non sequitur discussion.
Still, isn't it interesting....administering a medication in a way not intended by the manufacturer, nor approved by the FDA??
I hope our first 2 responses were helpful to you. Happy
- Sep 28, '08 by Happy HalothaneI responded earlier....but the post hasn't appeared (hours ago?)
In all fairness, I selected that article to help prove a point...for a discussion that cannot be won. There have been numerous studies regarding ESI since then: ESI is commonly practiced, as a result of evidenced-based medicine.
This discussion has circumlocuted away from your original question, but that's part of what makes forums interesting.
Still, isn't it interesting that medications are being administered in a way not intended by the manufacturer, nor approved by the FDA for that use?
I hope our initial responses were able to answer your question.
- Sep 28, '08 by paindocThere is no proof of the assertions in the Nelson paper. It is all conjecture based on supposition...he did NO STUDIES. Now if you have any PROOF as I asked for, by all means present it here. It is an insult to the intelligence of this forum to present an opinion paper as science. Surely have have heard of EBM and that OPINION holds virtually no weight at all, unless you are an anesthesiologist. Read the ASA website policy statements....they are based on primarily OPINION and totally disregard scientific process in establishing their dictums. Don't fall into the same trap as the anesthesiologists....if they say it, it must be true.... NOT!!!! Proof goes far beyond quoting 20 year old conjecture papers. There has never been published a scientific paper demonstrating the transferrance of PEG across the dura. It is all conjecture my friend.
As far as common usage, this is a legal defense. I serve as both an expert witness and on state medical review panels and am well versed in what is acceptable from a legal standpoint. I am sure you are also a nationally recognized expert in the field of pain medicine and understand the FDA process, common usage, off label usage, and the requirements for all of these....
Inadvertent subarachnoid injection of steroids, when done by stupid people that do not incorporate fluoroscopy with contrast, can cause arachnoiditis. However, if one knows what they are doing, can interpret in real time epidurograms, myelograms, and subdural injections using the STANDARD OF CARE WHICH IS FLUOROSCOPY (ISIS) with contrast confirmation for all spinal injections, then one would not even broach the subject. Alcohol, such as in Kenalog, can indeed cause problems when injected subarachnoid.
- Sep 28, '08 by sewnewMany thanks to you both for taking the time to answer my numerous questions.
There are just some days when it feels like I will never make it all the way to becoming a CRNA, but it is discussions like these that give me renewed strength to keep pursuing my goals.
- Oct 8, '08 by sleepy26Quote from sewnewOf course it can be incorrectly placed, you have to know what you're looking at. That's why you look at the flow patterns of contrast.Thank you both for your answers. They have been very informative.
One last question if you don't mind. If the ESI is performed under fluoroscopic guidance, does the possibility still exist that the needle can be placed in the wrong position? Would pain radiating down the patient's leg during the procedure (after the administration of the local anesthetic) indicate an incorrect needle position?
Any addition of fluid into the epidural space can place pressure on the nerve. The ability to recreate "their pain" during the injection is actually a good sign that you're in the right spot since that is where the medication is going. Of course if you're hitting the nerve with the needle that will hurt too - it's why you use contrast!
- Oct 8, '08 by sleepy26Quote from sewnewIn addition to the properties of the steroids, the practitioner may consider the particulate content in relation to where the injection will be. For example, methylprednisolone and triamcinolone are suspensions with particles. If the injection was inadvertently given in an artery, the small particles could embolize the artery and infarct the cord. Dexamethasone is commonly used in high risk cases such as cervical and high-lumbar ESIs.I was wondering...
What is the rationale for using one steroid over another in an epidural steroid injection? How does the CRNA decide which steroid to use?
I am particularly interested in the differences between Kenalog and Depo-Medrol. What are the pros and cons of using each?
Thanks in advance!
- Oct 9, '08 by paindocAgree with the caveat that some patients respond with radiating leg pain with the epidural needle in the multifidus musculature far outside the spine. The safest place for interlaminar injections are with the needle tip ending up dead midline. There are no exiting or traversing nerves that can be injured in the posterior epidural space midline. Particulate steroids (Celestone, Kenalog, Aristospan, Depomedrol) work longer than non-particulates. The epidural space is relatively vascular as can be seen when one injects contrast, then re-examines the patient under fluoroscopy 20 min later. The contrast is essentially all gone from the epidural space in many patients due to vascular uptake. Non-particulates are similarly rapidly removed from the epidural space and therefore do not work as well or as long as the particulates. However in highly vascular fields such as transforaminal injections or near the radicularis magnus, I agree the non-particulates are safer, albeit less effective.