From the Guidelines
Exparel (liposomal bupivacaine) is not recommended as a first-line treatment for postoperative pain management due to its high cost and inconsistent clinical benefits compared to standard bupivacaine, as evidenced by studies such as Sethi et al. 1 that showed mixed results in pain score reduction and opioid consumption. When considering the use of Exparel, several controversies come to mind, including its cost-effectiveness, marketing claims, and clinical benefits.
- The cost of Exparel is significantly higher than standard bupivacaine, which raises questions about its value in clinical practice, especially when studies like Koltka et al. 1 found better pain scores and less opioid consumption with interscalene continuous postoperative levobupivacaine 0.125% infusion compared to subacromial infusion.
- There have been concerns about misleading marketing claims regarding the duration of action of Exparel, with the FDA issuing a warning letter to the manufacturer in 2014 for overstating its effectiveness, which highlights the need for careful consideration of the evidence when making treatment decisions.
- Clinical trials have failed to demonstrate superior pain control compared to standard treatments, leading to debates about the true value of Exparel, as seen in studies such as Merivirta et al. 1 that found no significant difference in pain scores or opioid consumption between subacromial bupivacaine and placebo patch.
- Safety concerns have also emerged, including reports of chondrolysis when used intra-articularly, though this remains rare, and should be taken into account when weighing the risks and benefits of using Exparel.
- The use of Exparel in nerve blocks has been a topic of controversy, particularly before the FDA approved this indication in 2018, and its adoption rates among healthcare providers have varied due to cost concerns and inconsistent clinical benefits, as reported in studies such as Banerjee et al. 1 that found no difference in pain scores or opioid consumption between subacromial bupivacaine 0.25% infusion and saline infusion.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Controversies with Exparel
- The use of Exparel for peripheral nerve blocks has been associated with a higher incidence of adverse events, including nausea, pyrexia, pruritus, constipation, and vomiting 2.
- There is a lack of data on the long-term safety and efficacy of Exparel, particularly in pediatric patients 3.
- Exparel has not been approved for use in regional anesthesia, and its use for this purpose has been associated with inconsistent results and potential analgesic gaps 4.
- The safety of Exparel when administered by peripheral nerve block has been evaluated in animal studies, which have shown that it is well tolerated at doses up to 30 mg/kg, but may cause minimal to mild granulomatous inflammation of adipose tissue around nerve roots 5.
- The incidence of nervous system adverse events, including hypesthesia, has been reported to be higher in patients receiving Exparel compared to those receiving bupivacaine HCl or placebo 2.
- The use of Exparel has been associated with a higher incidence of cardiac adverse events, although the incidence is still relatively low 2.
Off-Label Use
- Exparel has been used off-label for peripheral nerve blocks, although its safety and efficacy for this purpose have not been fully established 2, 4.
- The use of Exparel for off-label indications may be associated with a higher risk of adverse events, and patients should be closely monitored for potential complications 2, 4.
Efficacy and Safety
- Exparel has been shown to be effective in providing postoperative pain control, although its efficacy may vary depending on the specific surgical procedure and patient population 6, 3.
- The safety profile of Exparel is generally similar to that of bupivacaine HCl, although it may be associated with a higher incidence of certain adverse events, such as nausea and vomiting 2.