Safety and Efficacy of Zynrelef® in Combination with a Single Unilateral or Bilateral Nerve Block Performed Prior to Surgery.

Journal of pain & relief Pub Date : 2023-01-01 Epub Date: 2023-10-05
Shiv Goel, Charles Luke, Matthew Holtzman, Benjamin Davies, Michael O'Malley, Dani Lavage, Carley Siedlecki, Jacques E Chelly
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Abstract

Purpose: The FDA recently approved Zynrelef® (A viscous solution of extended release of bupivacaine and meloxicam) to be applied at closure and providing postoperative analgesia for 72 hrs. Although the FDA didn't restrict the use of nerve blocks in combination with this formulation, the safety and efficacy of such a combination has yet to be documented. This quality improvement study investigated this combination within the FDA-approved indications.

Methods: Selected surgeons at two hospitals were chosen to use Zynrelef®. According to the standard of care, surgeons were also allowed to request single nerve blocks before surgery. The type of nerve blocks (unilateral or bilateral) performed included quadratus lumborum and paravertebral blocks for abdominal surgery, and adductor canal block for total knee replacement. Each block was performed with 20 mL of 0.375% bupivacaine (n=129) or 0.5% of ropivacaine (n=30). Pain scores, opioid consumption, and prescription refill requests at discharge were recorded. Patients discharged on the same day of surgery were separated into two groups-those who received single nerve blocks plus an Zynrelef® (group 1) vs. those receiving Zynrelef® only (group 2) and was analyzed using an un-paired t-test.

Results: A total of 184 patients received Zynrelef®, including 25 patients who didn't receive blocks, 44 who received unilateral blocks and 114 who received bilateral blocks. No symptoms suggestive of Local Anesthetic Toxicity (LAST) were observed. The use of the combination was associated with a 50% reduction in the number of patients filling their opioid prescription.

Conclusion: This study provides evidence that the combination of a single unilateral or bilateral nerve block with Zynrelef® is safe.

手术前单侧或双侧神经阻滞联合使用 Zynrelef® 的安全性和有效性。
目的:美国食品及药物管理局最近批准了 Zynrelef®(布比卡因和美洛昔康的缓释粘稠溶液),可在缝合时使用,并提供 72 小时的术后镇痛。尽管美国食品及药物管理局并未限制神经阻滞与这种制剂的联合使用,但这种联合使用的安全性和有效性仍有待证实。这项质量改进研究对 FDA 批准的适应症范围内的这种组合进行了调查:方法:两家医院的部分外科医生被选中使用 Zynrelef®。根据护理标准,外科医生也可在手术前要求进行单神经阻滞。进行的神经阻滞类型(单侧或双侧)包括腹部手术的腰四头肌和椎旁阻滞,以及全膝关节置换术的内收肌管阻滞。每次阻滞均使用20毫升0.375%布比卡因(129人)或0.5%罗哌卡因(30人)。记录了出院时的疼痛评分、阿片类药物用量和处方续订申请。手术当天出院的患者分为两组--接受单神经阻滞加Zynrelef®的患者(第1组)与仅接受Zynrelef®的患者(第2组),并采用非配对t检验进行分析:共有184名患者接受了Zynrelef®治疗,其中25名患者未接受阻滞治疗,44名患者接受了单侧阻滞治疗,114名患者接受了双侧阻滞治疗。没有观察到提示局麻药毒性(LAST)的症状。使用联合疗法后,患者开阿片类药物处方的人数减少了 50%:本研究提供了单侧或双侧神经阻滞与 Zynrelef® 联合使用是安全的证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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