28 Jan Study Finds EXPAREL Reduced Post-Surgical Opioids in Cesarean Section Patients
MedicalResearch.com Interview with:
Chief Executive Officer and Chairman
MedicalResearch.com: What is the background for this study?
Response: Cesarean sections (C-sections) are one of the most common surgeries in the United States, and research shows many women experience moderate to severe pain after this procedure. When postsurgical pain is inadequately managed for new mothers, it can interfere with recovery, maternal-infant bonding and may even lead to postpartum depression. Additionally, prescribing data reveals that postsurgical opioid consumption poses a great risk to women.
We recently completed a Phase 4 study of EXPAREL in C-section patients, and results revealed adding EXPAREL to bupivacaine transversus abdominis plane (TAP) blocks for C-section delivery provided significant reductions in opioids and pain scores. Results of that study provided the basis for the design of this next-generation study, which was created to be completely opioid-free in the EXPAREL arm.
The study was a Phase 4 multicenter, active-controlled study conducted in 18 clinical sites in the United States, with 169 enrolled patients undergoing elective C-section. The enrolled C-section patients were randomized to receive either 150 mcg morphine spinal anesthesia plus a standard of care postoperative pain regimen, 50 mcg morphine spinal anesthesia plus EXPAREL TAP field block, or opioid-free spinal anesthesia plus EXPAREL TAP block. Patients in the EXPAREL arms received a protocol-defined non-opioid postsurgical pain management regimen including ketorolac, acetaminophen, and ibuprofen.
MedicalResearch.com: What are the main findings? How does EXPAREL differ from other pain medications?
Response: The main findings of this study include EXPAREL demonstrated a statistically significant reduction in total postsurgical opioid consumption while managing pain through 72 hours. The study also demonstrated that EXPAREL reduced the incidence and severity of itching for 72 hours after surgery, which can be an incredibly unpleasant opioid-related side effect for new mothers tasked with both recovering and taking care of their newborns.
EXPAREL differs from other pain medications in that it provides significant, long-lasting pain control while reducing or eliminating the need for opioids after surgery. More than 6 million patients have received EXPAREL since 2012.
EXPAREL is infiltrated into the plane between the transverse muscle and the abdominis muscle, in close proximity to the sensory nerves, and releases a numbing medication for the first few days following surgery when pain is often at its worst. As a non-opioid, EXPAREL significantly reduces the risk for unwanted opioid-related side effects, such as drowsiness, itching, nausea, vomiting and constipation.
MedicalResearch.com: What should readers take away from your report?
Response: Opioid addiction in women is growing at an alarming rate, with recent studies showing women are 40% more likely to become newly persistent users of opioids following surgery, meaning they are still taking opioids 3 to 6 months after their procedure.
This data reiterates that we should not be complicit with the current standard of care for new mothers giving birth via C-section, especially if a woman expresses concern about the risks associated with opioids. In light of the ongoing opioid epidemic, it is imperative that clinicians continue to evolve practices to include the safest and most effective methods in medicine, and patients advocate for themselves by discussing non-opioid options such as EXPAREL with their health care providers before surgery. Opioids no longer need to be our primary option for pain management. Non-opioid options, such as EXPAREL, can provide a much-needed turning point in a new wave of pain management.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Full study results will be submitted for publication in peer-reviewed medical literature later this year. We are continuing to study EXPAREL in pediatric patients, a population that currently has no non-opioids approved to treat postsurgical pain, as well as in lower extremity nerve block cases in orthopedic procedures.
MedicalResearch.com: Is there anything else you would like to add?
Response: Pacira BioSciences, Inc. provided support for this study. Dave Stack is Chief Executive Officer and Chairman of Pacira BioSciences, Inc.
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