[article] in Journal of the American Podiatric Medical Association > Vol. 111, 03 (Mai-juin 2021) Titre : | Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia | Type de document : | article de périodique | Auteurs : | Richard A. Pollak ; Danlin Cai ; Tong J. Gan | Année de publication : | 2021 | Langues : | Anglais (eng) | Descripteurs (mots clés) : | [Thésaurus Mesh]:H:Hallux valgus:Hallux valgus / chirurgie [Thésaurus Mesh]Analgésiques [Thésaurus Mesh]Douleur [Thésaurus Mesh]Douleur postopératoire [Thésaurus Mesh]Pied
| Mots-clés : | Méloxicam bunionectomie | Résumé : | Background: There is a need for postoperative pain control that minimizes or eliminates opioid use during the first 72 hours following surgery, when pain is most severe. HTX011 is an extended-release, dual-acting local anesthetic that demonstrated superior 72- hour analgesia over standard of care bupivacaine hydrochloride (HCl) and saline placebo in a phase 3 bunionectomy study (EPOCH-1). Having shown HTX-011 monotherapy is superior to bupivacaine HCl in reducing postoperative pain intensity and opioid use, this follow-on study evaluated the safety and efficacy of HTX-011 as the foundation of a multimodal analgesia (MMA) regimen using over-the-counter medications recommended by practice guidelines for pain management. Methods: Following regional anesthesia administered as a lidocaine block, patients underwent unilateral bunionectomy with osteotomy and internal fixation. Prior to closure, HTX-011 (up to 60 mg bupivacaine/1.8 mg meloxicam) was applied without a needle. Patients received scheduled postoperative MMA alternating ibuprofen (600 mg) and acetaminophen (1 g) every 3 hours for 72 hours. Efficacy was assessed based on pain intensity (numeric rating scale [NRS; 0–10]) and consumption of opioid rescue medication (intravenous morphine milligram equivalents [MME]). Adverse event and vital sign monitoring, plus laboratory and wound healing assessments, were used to determine safety. Results: Over the 72-hour assessment period following bunionectomy, mean pain scores were mild in severity (NRS ,4) and 22/31 patients (71%) experienced no severe pain (NRS 7) with HTX-011 as the foundation of scheduled, non-opioid MMA. Patients consumed an average of 1.61 MME total, with 24/31 (77%) requiring no opioid rescue medication (opioid-free). HTX-011 was well-tolerated and demonstrated no safety concerns with the inclusion of postoperative MMA. Conclusions: HTX-011 as the foundation of an MMA regimen including scheduled ibuprofen and acetaminophen maintained mean postoperative pain scores in the mild range and enabled opioid-free recovery for 77% of bunionectomy patients through the 28-day recovery period. | Permalink : | https://bibliotheque.helb-prigogine.be/opac_css/index.php?lvl=notice_display&id= |
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