HTX-011 yielded mild pain scores, reduced opioid use after bunionectomy
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Published results showed HTX-011 may lead to mild postoperative pain scores and reduced opioid use after bunionectomy.
In this follow-up to the EPOCH-1 study, 31 patients undergoing unilateral, distal bunionectomy of the first metatarsal with osteotomy and internal fixation received a dual-acting local anesthetic comprised of up to 60 mg bupivacaine and 1.8 mg meloxicam (HTX-011, Heron Therapeutics) prior to closure. Postoperatively, patients received multimodal analgesia alternating ibuprofen and acetaminophen every 3 hours for 72 hours. Researchers assessed efficacy based on pain intensity and consumption of opioid rescue medication. Researchers also used adverse event and vital sign monitoring, as well as laboratory and wound healing assessments to determine safety.
Mean pain scores were mild in severity during the 72-hour assessment period, with 71% of patients reporting no severe pain. Researchers found patients consumed an average of 1.6 morphine milligram equivalents total. Overall, 77% of patients did not require opioid rescue medication, according to results. Researchers noted HTX-011 demonstrated no safety concerns with the inclusion of postoperative multimodal analgesia.
“The EPOCH-1 follow-on study demonstrated that HTX-011 as the foundation of a multimodal non-opioid regimen can keep pain in the mild range and substantially reduce the need for, and in some cases completely eliminate, opioids for patients following bunionectomy, a painful surgical procedure,” Barry Quart, PharmD, chair and CEO of Heron Therapeutics, told Healio Orthopedics. “In the EPOCH-1 follow-on study, 77% of patients required no opioids through the 28-day recovery period. Importantly, the results of this study may provide orthopedics with a model for managing severe, postoperative pain for patients undergoing complex and painful surgeries and the ability to reduce or eliminate the need for opioid prescriptions with a simple multimodal design.”
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This study investigates the use of a novel local anesthetic containing HTX-011, a combination of bupivacaine and meloxicam, used in conjunction with scheduled oral ibuprofen and acetaminophen after open bunion surgery. The authors compared the results of this multi-modal approach to postoperative pain with a similar trial (EPOCH-1 trial) using HTX-011 alone. The results are indeed impressive. A significant number of patients, 71%, required no opioid rescue after surgery and without any major adverse effects.
Using a 24-hour popliteal block with bupivacaine and a similar postoperative multi-modal approach regimen, I have noted the same results in my practice after hallux valgus surgery. Avoiding a more invasive nerve block with rare, but potentially debilitating, complications would certainly benefit patients. In addition, for those surgeons who do not have access to peripheral block specialists, this topical medication would allow an opioid-free postoperative course for most patients undergoing forefoot corrective surgery.
This small, 30-patient study serves as an excellent pilot investigation but, because it was sponsored by the maker of HTX-011 and the authors received financial support and honoraria, significant conflicts muddy the results. Hopefully, this prompts a larger independent study comparing this approach directly to popliteal blocks with a multi-modal approach in the outpatient setting.
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