MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This was a multicenter study conducted in 13 clinical sites in the United States enrolling patients undergoing elective Cesarean-section and receiving spinal anesthesia. 186 patients were enrolled and randomized to receive EXPAREL, a long-acting, non-opioid option to manage postsurgical pain, administered via transversus abdominis plane (TAP) field block, mixed with plain bupivacaine or TAP block with plain bupivacaine alone. A TAP block numbs the nerves that supply the abdominal wall. We presented the data at the 51st Annual Meeting of the Society of Obstetric Anesthesia and Perinatology (SOAP) in Phoenix, AZ.
We aimed to collect clinical evidence that a multimodal postsurgical pain regimen using a TAP block with EXPAREL (bupivacaine liposome injectable suspension) together with regularly scheduled acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) could reduce opioid consumption more so than a standard multimodal pain control approach that combines TAP block with standard bupivacaine, regularly scheduled acetaminophen, and NSAIDs.
MedicalResearch.com: What are the main findings?
Response: The study found that patients receiving an EXPAREL TAP block experienced a statistically-significant reduction in total postsurgical opioid consumption, as well as significant reduction in pain intensity scores through 72 hours (52%). Further, it achieved a statistically significant reduction in total opioid consumption at one week (49%) and two weeks (41%) following C-section.
Additionally, the percentage of opioid-spared patients was more than two times higher in the EXPAREL group rather than the standard bupivacaine group (54% vs 25%).
MedicalResearch.com: What should readers take away from your report?
Response: Inadequately managed postsurgical pain following cesarean delivery can increase the risks of persistent pain and opioid use, as well as postpartum depression. Despite the use of multimodal pain management regimens, many women still experience pain necessitating the use of rescue opioid analgesics following cesarean delivery.
This study provides clinical evidence that EXPAREL alongside an opioid-sparing multimodal regimen not only provides prolonged pain relief, but also greatly reduces the need for opioids. 54% of patients in this study took no more than one opioid pill and had no opioid-related side effects through 72 hours.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Studies show that women are 40% more likely than men to become newly persistent users of opioids following surgery1. To assist this vulnerable population, we must continue to study the effectiveness of non-opioid options that reduce the need for opioids after surgery. Even more, we must continue to improve the standard of care for patients undergoing surgery. Providing viable non-opioid pain management options is a step in the right direction, especially considering the ongoing opioid epidemic. As physicians, now more than ever, we must be aware of our prescribing practices and avoid becoming complacent when positive change is needed.
MedicalResearch.com: Is there anything else you would like to add?
Response: Ashraf Habib, MD, Chief of the Division of Women’s Anesthesia and Professor of Anesthesiology at Duke University was a study investigator and presented this research at the 51st Annual Meeting of the Society of Obstetric Anesthesia and Perinatology (SOAP).
Pacira Pharmaceuticals provided support for this study.
1 Pacira. United States for Non-Dependence: An Analysis of the Impact of Opioid Overprescribing in America. September 2017. [Analysis in the report was based on research conducted by the QuintilesIMS Institute.]
Data were presented from the podium at the 51st Annual Meeting of the Society of Obstetric Anesthesia and Perinatology (SOAP)
EXPAREL during C-sections provides prolonged pain relief and greatly reduces the need for opioids
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