EXPAREL for Post-surgical Pain Relief

This trial tests two pain relief methods for individuals undergoing total ankle replacement surgery. It compares the effects of a single dose of EXPAREL, a long-lasting anesthetic, with 0.25% bupivacaine, a common painkiller. The study evaluates how well these drugs manage pain, reduce opioid use, and improve patient satisfaction. Participants should plan to have a single ankle replacement and not have other major pain conditions or certain medical issues. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants an opportunity to contribute to the development of potentially groundbreaking pain relief options.

The trial does not specify if you need to stop taking your current medications. However, if you have a painful condition requiring regular pain medication or use opioids regularly, you may not be eligible to participate.

A previous study found that EXPAREL, a long-lasting form of the pain reliever bupivacaine, was well-tolerated by patients. Common side effects included stomach pain, irritation at the injection site, and headaches, but these were not severe. The FDA has approved EXPAREL for pain relief after surgery, which supports its safety.

Research on 0.25% bupivacaine (HCl) has shown it is generally well-tolerated as well. It is used to numb areas during surgery and can cause heart-related side effects if administered in high doses. However, it is considered safe when used correctly.

Unlike the standard of care for post-surgical pain, which often relies on traditional anesthetics like bupivacaine alone, EXPAREL offers a unique approach by combining it with bupivacaine for extended relief. Researchers are excited about EXPAREL because it uses bupivacaine encapsulated in a lipid-based delivery system, allowing for a gradual release that can provide longer-lasting pain control. This means patients could potentially experience effective pain relief for a longer period after surgery, reducing the need for additional pain medication and improving overall recovery.

Research has shown that EXPAREL, a special form of the pain reliever bupivacaine, effectively manages post-surgical pain. In this trial, participants will receive either EXPAREL combined with 0.25% bupivacaine HCl or bupivacaine HCl alone. Studies have found that patients receiving EXPAREL often report less pain and require fewer opioids for pain management after surgery. Specifically, one study noted that most patients using EXPAREL were satisfied with their pain relief 72 hours post-surgery. While traditional bupivacaine works well for some longer surgeries, it typically does not provide as much pain relief or reduce opioid use as effectively as EXPAREL. Overall, evidence suggests that EXPAREL may offer better pain control after surgery compared to regular bupivacaine.⁴⁶⁷⁸⁹