HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study.

Autor:	Lee GC; Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania., Berkowitz R; University Orthopedic and Joint Replacement Center, Tamarac, Florida., Hacker S; Grossmont Orthopedic Medical Group, La Mesa, California., Hu J; Heron Therapeutics, Inc., San Diego, California., Rechter A; Department of Orthopaedic Surgery, Orthopaedic Associates, LLP, Houston, Texas.
Jazyk:	angličtina
Zdroj:	The journal of knee surgery [J Knee Surg] 2023 Jul; Vol. 36 (9), pp. 925-932. Date of Electronic Publication: 2022 Jun 10.
DOI:	10.1055/s-0042-1747945
Abstrakt:	Total knee arthroplasty (TKA) can be associated with significant postoperative pain despite multimodal analgesic (MMA) protocols, and most patients require the use of opioids postoperatively. HTX-011 is a dual-acting local anesthetic containing bupivacaine and low-dose meloxicam in an extended-release polymer. In a prior randomized controlled trial (RCT), HTX-011 reduced pain and opioid use through 72 hours after TKA compared with bupivacaine hydrochloride. This open-label study (NCT03974932) evaluated the efficacy and safety of HTX-011 combined with an MMA regimen in patients undergoing TKA under spinal anesthesia. All patients received intraoperative HTX-011 (400 mg bupivacaine/12 mg meloxicam) in combination with an MMA regimen consisting of preoperative acetaminophen, celecoxib, and pregabalin and postoperative acetaminophen and celecoxib until discharge. Opioid rescue was allowed upon patient request for additional pain control. Pain scores, opioid consumption, discharge readiness, and adverse events were recorded. Fifty-one patients were treated. Compared with the prior RCT, HTX-011 with this MMA regimen further lowered pain scores and reduced opioid use. Mean patient-reported pain scores remained in the mild range, and 82% of patients or more did not experience severe pain at any individual time point through 72 hours after surgery. Mean total opioid consumption was low over 72 hours: 24.8 morphine milligram equivalents (1-2 tablets of oxycodone 10 mg/day). Approximately 60% of patients were ready for discharge by 12 hours, and 39% were discharged without an opioid prescription and did not call back for pain management. The treatment regimen was well tolerated, and no added risk was observed with the addition of MMA. HTX-011 with an MMA regimen reduced postoperative pain and opioid use following TKA. Competing Interests: G.-C.L. reports the following: Personal fees as a paid consultant from: Heron Therapeutics, Inc., Stryker, and Corin; research support as a principal investigator from: Smith and Nephew, Deeny, KCI Acelity, outside the submitted work; medical/orthopaedic publications editorial/governing board: Journal of Arthroplasty, Clinical Orthopaedics and Related Research, Journal of Bone and Joint Surgery, Bone & Joint Journal.Board member: Knee Society - Technology Committee.R.B. reports personal fees as a paid consultant and research support from Heron Therapeutics, Inc., during the conduct of the study and personal fees as a paid consultant from Baudax Bio and research support from Janssen outside the submitted work.S.H. reports personal fees as a paid consultant from Heron Therapeutics, Inc., and research support as a principal investigator from Aesculap, Cartiheal, Biosolution Ltd, Active Implants, Novartis, and MiMedx during the conduct of the study.J.H. reports personal fees from Heron Therapeutics, Inc. and stock options from Heron Therapeutics, Inc. during the conduct of the study.A.R. reports personal fees as a paid consultant from Heron Therapeutics, Inc. during the conduct of the study. (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
Databáze:	MEDLINE
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