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duced the exact same result. Therefore, they are irrelevant to this discussion. The first was a
study of colectomy patients; it compared PCA opioid analgesia (rather than bupivacaine)
to a multimodal analgesic approach that included Exparel. It was also underpowered, with
only 39 patients. The second study looked at microvascular breast reconstruction. It com-
pared multimodal anesthesia including Exparel to an unspecified (and apparently highly
variable) retrospective cohort of patients who received "traditional care after surgery." The
lead author of the second study is a Pacira consultant and the lead author of the third
study is a Pacira stockholder.
While we haven't seen Dr. Faley's study, it also appears to be of questionable relevance,
since it compares Exparel to PCAs and epidurals, not bupivacaine.
Finally, Dr. Faley writes that we should have factored in the results of 2 more studies in
our analysis of Exparel vs. bupivacaine. We've addressed one of the studies above. The
second study is likewise unconvincing:
• While it shows that 266 mg Exparel is superior to 75 mg bupivacaine, the other 2 for-
mulations of Exparel did not exhibit statistically significant differences from 75 mg bupi-
vacaine. That result begs the question: If the researchers had tested 75 mg bupivacaine
against 266 mg bupivacaine, would they have arrived at the same result?
• The study is underpowered, with only 25 patients in each arm. The authors admit that
the "study was not originally powered to take multiple comparisons into account."
• The bupivacaine study group is significantly skewed toward women. It's 42% female.
By contrast, the 266 mg Exparel group is only 12% female. That's important because stud-
ies show women feel pain more intensely than men.
• The difference the study found in opioid consumption is very small, just one 5 mg
Percocet more per day.
• The lead author of the study received $50,000+ from Pacira in 2013, and a Pacira
employee is the second author.
The question we raise in our article is not whether Exparel works. Clearly it does. The
question is whether the data show that it works any better than bupivacaine. From our
analysis of the data, the answer appears to be no. — The Editors
