Evaluation of Efficacy of 2 Extended-release Bupivacaine Products in a Porcine Model of Incisional Pain.

Peggy Yang, Stephanie Yang, Laura B Durham, Patrick A Lester, Daniel D Myers
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Abstract

Extended-release (ER) local anesthetics are often incorporated in multi-modal analgesia or as an alternative when the effect of systemic analgesics may confound research. In this study, we compared the analgesic efficacy of 2 ER bupivacaine anesthetics with different ER mechanisms, a slow-release bupivacaine-meloxicam polymer (BMP) and a sucrose acetate isobutyrate bupivacaine (SABER-B) system. We used a full-thickness unilateral skin incision porcine model to evaluate the efficacy of these 2 ER bupivacaine analgesics. Eighteen male swine were randomized into 3 groups: control (saline; n = 6), bupivacaine:meloxicam (10 mg/kg, 0.3 mg/kg; n = 6), and SABER-B (10 mg/kg; n = 6). After surgery, pigs were assessed for changes in body weight, salivary cortisol level, and response to von Frey testing at 1, 3, 6, 24, 48, 72, 96, 120, and 168 h. Body weight and salivary cortisol levels were not significantly different between groups. Based on the von Frey testing, the pigs that received analgesics showed a significantly higher withdrawal threshold of nociceptive stimulus than those that received saline at 1, 3, 6, and 24 h after the surgery. At 48 h after surgery, the SABER-B group had a significantly higher withdrawal threshold than the saline group. The withdrawal threshold was not significantly different from the baseline measurement on intact skin at 3 and 6 h after surgery in the BMP group or 1 and 3 h for the SABERB group. The analgesic effects of BMP were greatest at 3 and 6 h after surgery and that of SABER-B as 1 and 3 h SABER-B provided an earlier onset of analgesia and longer analgesia duration than did BMP. This study demonstrates that ER bupivacaine can provide pigs with 24 to 48 h of analgesia for incisional pain.

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在猪切口疼痛模型中评估两种布比卡因缓释产品的疗效
缓释(ER)局麻药通常被用于多模式镇痛,或者在全身镇痛药的效果可能会影响研究时作为一种替代品。在这项研究中,我们比较了两种具有不同ER机制的ER布比卡因麻醉剂的镇痛效果,一种是缓释布比卡因-美洛昔康聚合物(BMP),另一种是蔗糖醋酸异丁酸布比卡因(SABER-B)系统。我们使用全厚单侧皮肤切口猪模型来评估这两种ER布比卡因镇痛剂的疗效。18 头雄性猪被随机分为 3 组:对照组(生理盐水;n = 6)、布比卡因:美洛昔康(10 毫克/千克,0.3 毫克/千克;n = 6)和 SABER-B(10 毫克/千克;n = 6)。手术后,分别在 1、3、6、24、48、72、96、120 和 168 小时评估猪的体重变化、唾液皮质醇水平以及对 von Frey 试验的反应。根据 von Frey 测试结果,在手术后 1、3、6 和 24 小时,接受镇痛剂的猪对痛觉刺激的戒断阈值明显高于接受生理盐水的猪。术后 48 小时,SABER-B 组的戒断阈值明显高于生理盐水组。BMP 组术后 3 小时和 6 小时或 SABERB 组术后 1 小时和 3 小时的退缩阈值与完整皮肤上的基线测量值没有明显差异。BMP 的镇痛效果在术后 3 和 6 h 最大,而 SABER-B 的镇痛效果在术后 1 和 3 h 最大,因为 SABER-B 比 BMP 的镇痛起效更早,镇痛持续时间更长。这项研究表明,ER 布比卡因可为猪提供 24 到 48 小时的切口疼痛镇痛。
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