Neil Singla1, Peter Winkle2, Todd Bertoch3, Jia Hu4, Alina Beaton5, Jay Redan6. 1. Lotus Clinical Research, LLC, Pasadena, CA. Electronic address: nsingla@lotuscr.com. 2. Anaheim Clinical Trials, Anaheim, CA. 3. JBR Clinical Research, Salt Lake City, UT. 4. Heron Therapeutics, San Diego, CA. 5. Lotus Clinical Research, LLC, Pasadena, CA. 6. Advent Health-Celebration, Celebration, FL.
Abstract
BACKGROUND: Most severe pain occurs within the first 72 hours after an operation, and current local anesthetics have a limited duration of action. HTX-011 is a dual-acting, local anesthetic containing bupivacaine, and low-dose meloxicam in an extended-release polymer. In a prior phase 3 inguinal herniorrhaphy study, HTX-011 alone provided superior pain relief for 72 hours and significantly decreased opioid use compared with saline placebo and bupivacaine hydrochloride. This open-label study assessed the safety, efficacy, and opioid-sparing properties of HTX-011 as the foundation of a scheduled, nonopioid, multimodal analgesia regimen in patients undergoing open inguinal herniorrhaphy. METHODS: This study was conducted in 2 sequential cohorts. All patients received a single, intraoperative dose of HTX-011 prior to wound closure, followed by a scheduled postoperative regimen of oral ibuprofen and acetaminophen for 72 hours. Patients in cohort 2 also received a single intraoperative dose of ketorolac. Opioid analgesics were available by request only. RESULTS: More than 90% of patients remained opioid-free through 72 hours postoperatively, and 83% of patients remained opioid-free through day 28 (last study visit). Pain was well controlled, and mean intensity of the pain never increased higher than the mild range during the first 72 hours. Ketorolac did not demonstrate any additional benefit. HTX-011 with this multimodal analgesia regimen was well tolerated. CONCLUSION: HTX-011 when used as the foundation of a nonopioid, multimodal analgesia regimen, provided effective and well-tolerated analgesia without the need for opioids in the majority of patients recovering from an open inguinal herniorrhaphy.
BACKGROUND: Most severe pain occurs within the first 72 hours after an operation, and current local anesthetics have a limited duration of action. HTX-011 is a dual-acting, local anesthetic containing bupivacaine, and low-dose meloxicam in an extended-release polymer. In a prior phase 3 inguinal herniorrhaphy study, HTX-011 alone provided superior pain relief for 72 hours and significantly decreased opioid use compared with saline placebo and bupivacaine hydrochloride. This open-label study assessed the safety, efficacy, and opioid-sparing properties of HTX-011 as the foundation of a scheduled, nonopioid, multimodal analgesia regimen in patients undergoing open inguinal herniorrhaphy. METHODS: This study was conducted in 2 sequential cohorts. All patients received a single, intraoperative dose of HTX-011 prior to wound closure, followed by a scheduled postoperative regimen of oral ibuprofen and acetaminophen for 72 hours. Patients in cohort 2 also received a single intraoperative dose of ketorolac. Opioid analgesics were available by request only. RESULTS: More than 90% of patients remained opioid-free through 72 hours postoperatively, and 83% of patients remained opioid-free through day 28 (last study visit). Pain was well controlled, and mean intensity of the pain never increased higher than the mild range during the first 72 hours. Ketorolac did not demonstrate any additional benefit. HTX-011 with this multimodal analgesia regimen was well tolerated. CONCLUSION: HTX-011 when used as the foundation of a nonopioid, multimodal analgesia regimen, provided effective and well-tolerated analgesia without the need for opioids in the majority of patients recovering from an open inguinal herniorrhaphy.
Authors: Alan D Kaye; Amber N Edinoff; Justin Y Yan; Aaron J Kaye; Michael A Alvarado; Alex D Pham; Azem A Chami; Rutvij J Shah; Bruce M Dixon; Amineh Shafeinia; Elyse M Cornett; Charles Fox Journal: Anesth Pain Med Date: 2022-02-14