PainRelief.com Interview with:
Dr. Ashraf Habib, MB BCh
Chief of the Division of Women’s Anesthesia
Professor of Anesthesiology
Duke University, Durham, NC
PainRelief.com: What is the background for this study?
Response: Cesarean sections (C-sections) occur every day in the United States, with more than 1.2 million procedures in the US each year according to the CDC. Since postsurgical pain after C-sections can range from moderate to severe discomfort, it is important that this pain is managed effectively and safely. The amount of pain experienced and the way pain is treated can have an impact on a new mother’s postsurgical recovery. While opioids were once considered the standard treatment to manage pain after surgery, postsurgical opioid consumption can have a negative impact on a new mother’s recovery experience, causing unwanted side effects such as drowsiness, itching, nausea, vomiting, constipation and the risk of persistent use or dependence. In fact, research shows nearly nine in 10 mothers and mothers-to-be have concerns about taking opioids during and after childbirth, yet 51% of all C-section patients are still prescribed an opioid to manage postsurgical pain.
We recently published results from a Phase 4 study in Anesthesia and Analgesia that revealed the long-acting local anesthetic EXPAREL (bupivacaine liposome injectable suspension), when administered with bupivacaine as part of transversus abdominis plane (TAP) field block, provided a significant reduction in opioid consumption and a greater percentage of opioid-spared patients, with optimized pain control through 72 hours. This was a multicenter, randomized, double-blind study across 13 clinical sites in the United States, in patients undergoing elective C-section and receiving spinal anesthesia and a multimodal analgesic regimen. Patients were randomized to receive EXPAREL 266 mg plus bupivacaine HCl 50 mg or bupivacaine HCl 50 mg alone administered via TAP field block after delivery.
PainRelief.com: Would you briefly explain what EXPAREL contains and how it is administered?
Response: EXPAREL is a long-acting local anesthetic that is injected into the surgical site during a procedure to provide non-opioid pain control for the first few days after surgery when patients often need it the most. EXPAREL utilizes DepoFoam®, a multivesicular liposomal delivery technology that encapsulates bupivacaine and slowly releases it over time as the DepoFoam carrier matrix breaks down. This results in prolonged pain control with a single-dose administration of EXPAREL. Additional information on EXPAREL is available at www.EXPAREL.com.
PainRelief.com: What are the main findings?
Response: TAP Block with EXPAREL showed success in reducing opioid consumption in patients undergoing C-sections. Specifically, TAP block with EXPAREL demonstrated a 52% reduction in opioid consumption through 72 hours and a 49% reduction at one week after surgery. The percentage of opioid-spared patients, defined as patients who took no more than one 10 mg oxycodone tablet (or equivalent) with no opioid-related side effects through 72 hours, was also 2.2 times higher in the EXPAREL group vs the bupivacaine group
The findings from this study demonstrate that a multimodal regimen incorporating TAP block with EXPAREL has the potential to change the standard of care for women undergoing C-section patients.
PainRelief.com: What should readers take away from your report?
Response: A recent survey found that 54% of women didn’t discuss non-opioid pain management options because they trust their doctor’s recommendation, and 19% of women aren’t even aware that non-opioid treatments are an option for managing postsurgical pain. As a physician, it is my responsibility to be knowledgeable of the alternatives available for my patients, to educate them about their options, and incorporate best evidence in my practice to enhance patients’ recovery. My hope is that this study can bring to light the positive effect that multimodal analgesia including non-opioid options, such as scheduled oral non-opioid pain killers and TAP block with EXPAREL, can have on pain control after C-sections, while also limiting our over reliance on opioids. Those non-opioid options can help mitigate the unwanted side effects of opioid use while also providing patients with a more positive recovery
Any disclosures? This study was supported by Pacira BioSciences, Inc.
Citation: Nedeljkovic, Srdjan S. MD*; Kett, Attila MD†; Vallejo, Manuel C. MD, DMD‡; Horn, Jean-Louis MD§; Carvalho, Brendan MBBCh§; Bao, Xiaodong MD, PhD‖; Cole, Naida M. MD*; Renfro, Leslie MD¶; Gadsden, Jeffrey C. MD#; Song, Jia MS**; Yang, Julia MD, MBA**; Habib, Ashraf S. MB, BCh# Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial, Anesthesia & Analgesia: July 21, 2020 – Volume Publish Ahead of Print – Issue –
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