Saturday, May 24, 2008

DepoDur Warnings

I was preparing to submit a pharmacy request to add DepoDur (liposomally encapsulated epidural morphine) to our formulary what I ran across this nugget:

FDA Warns of Settings That Increase Risk for Respiratory Depression From Morphine Sulfate Extended-Release Liposome Injection (DepoDur)

On December 14, 2007, the FDA approved safety labeling revisions for morphine sulfate extended-release liposome epidural injection (DepoDur; Skye Pharma Inc) to warn of settings associated with an increased risk for respiratory depression.

Although the formulation is intended for administration by the epidural route only, postmarketing reports have included cases of intrathecal use. In all cases, signs of prolonged respiratory depression required use of a narcotic antagonist (naloxone) or ventilatory support.

Because a breached dural membrane can lead to intrathecal leakage, particularly when the epidural drug is administered in a bolus, vigilant monitoring of respiratory function for a prolonged period (48 hours) is advised when extended-release morphine sulfate liposome injection is administered after a recent dural puncture. Provision should be made for emergency ventilation to minimize the risk for serious respiratory depression.

Subarachnoid puncture during epidural administration of the product has also been linked to cases of prolonged and serious respiratory depression or apnea, occurring within 12 hours of injection and after apparent recovery from anesthesia. Respiratory depression can be successfully treated with a naloxone bolus or, more commonly, a naloxone infusion; intubation and mechanical ventilation may be necessary in some cases.

Morphine sulfate extended-release liposome injection is indicated for single-dose epidural administration at the lumbar level to treat postoperative pain; it is given before surgery or after clamping the umbilical cord during cesarean delivery. The injection is not intended for intrathecal, intravenous, or intramuscular administration.

Sunday, May 6, 2007

I'm a Better Anesthesiologist Today Than A Year Ago

At the end of this busy week I began to reflect on how this week was different than an average week would have been even a year ago.  It was different both for me and for a significant number of my patients.  Hopefully, it was as good for patients as it was for me.

For the first ten years after I finished my training I did not believe nerve blocks for extremity surgery were worth doing.  Surgeons didn't want to wait for me to do them or for the blocks to 'set up.'  Blocks failed a certain amount  of the time. There were complications that just didn't happen when 'numbing the big nerve.'

My thoughts on all this changed, not because of a journal article or discussions with a colleague, but because of an article in Wired magazine.  The Painful Truth was an article on the use of regional anesthesia to improve medical care to our wounded soldiers in Iraq and Afghanistan:

Now Buckenmaier is leading a group of army doctors and nurses determined, as he puts it, "to drag the military kicking and screaming into the 21st century." His team believes the future of wartime pain control is a new form of anesthesia called a continuous peripheral nerve block, which takes a more targeted approach by switching off only the pain signals coming from the injured limb, leaving patients' vital signs and cortical functions unimpaired.

The applicability to civilian anesthesia was obvious.  In my hospital, when someone gets a knee replaced, the surgeon usually blindly injects a large amount of local anesthetic in the general vicinity of the femoral nerve and we dope them up with morphine.  Patients are in the hospital for three days largely for pain control issues, all the while at risk for nausea, vomiting, respiratory depression, etc.

I took a second look at regional anesthesia and decided to use it in my practice again.  This week two elderly ladies had total shoulder replacements after having interscalene blocks. They were pain free for the rest of that day.  Six of my patients had knee replacements after femoral and sciatic blocks.  They had no pain until the next morning.

With catheter techniques, these pain-free intervals will be measured in days instead of hours.  The surgeons are giving us the time to do these techniques because they are hearing about how good they are for patients at their own national meetings.  My colleagues who 'didn't do blocks' have learned to do simple femoral nerve blocks and want to learn others.

It was a good week for me because I love seeing patients do well. It was a good week for my patients (whether they knew it or not) because they trusted me enough to let me poke them with a needle once or twice to make their recovery that much easier.  By next year I hope to be placing catheters and doing infusions.  Thanks, Trip Buckenmaier.

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