【罂粟摘要】布比卡因脂质体用于腹横肌平面阻滞治疗剖宫产术后疼痛的多中心、随机、双盲研究
布比卡因脂质体用于腹横肌平面阻滞治疗剖宫产术后疼痛的多中心、随机、双盲研究
对于在鞘内吗啡腰麻下剖宫产的妇女，用盐酸布比卡因(HCl)经腹横肌平面(TAP)阻滞可能不能改善术后镇痛。这可能与盐酸布比卡因作用时间较短有关。一项回顾性研究报告称，剖宫产后使用长效脂质体布比卡因(LB)阻滞可减少阿片类药物的消耗并改善镇痛效果。因此，我们进行了一项前瞻性的多中心、随机、双盲试验，检测LB加盐酸布比卡因与单独使用盐酸布比卡因的TAP阻滞的有效性和安全性。
纳入186例在腰麻下择期剖宫产的足月妊娠产妇，随机（1:1）分为LB 266 mg+盐酸布比卡因50 mg或单用盐酸布比卡因50 mg两组。在一个事先定义的方案符合性分析（PCA）中评估疗效。主要观察指标是术后72小时内阿片类药物的总消耗量（口服吗啡等效剂量[MED]）。疼痛强度用视觉模拟量表测量。治疗后第14天记录不良事件（AEs）。
与单用盐酸布比卡因相比，LB加盐酸布比卡因可减少72小时的阿片类药物总消耗量(最小二乘法平均[LSM][标准差(SE)]MED，15.5 mg[6.67 mg]vs 32.0 mg[6.25 mg])。这相当于LSM治疗的差异为−16.5mg(95%可信区间[CI]，−30.8至−2.2mg；P=0.012)。72小时归因性疼痛强度评分曲线下面积支持LB加盐酸布比卡因与单用盐酸布比卡因的非劣性(LSM[SE]，147.9[21.13]vs 178.5[19.78]；LSM治疗差异，−30.6；95%CI，−75.9~14.7)，预先指定的非劣性界限为36(P=0.002)。在对所有接受治疗的患者(包括那些不符合纳入PCA标准的患者)的分析中，术后阿片类药物的使用量在两组之间没有差异。在LB+盐酸布比卡因组中，63.6%的患者在治疗后经历了AE，而单独使用盐酸布比卡因组的比例为56.2%。治疗后严重不良反应少见(两组≈均为3%)。
使用LB加盐酸布比卡因作为鞘内注射吗啡的多模式镇痛方案的一部分完成TAP阻滞，可减少PCA组剖宫产后阿片类药物的用量。结果表明，在正确实施TAP阻滞和坚持多模式术后镇痛方案的情况下，布比卡因+LB进行TAP阻滞可减少剖宫产后产妇阿片类药物的使用。
Srdjan S. Nedeljkovic, Attila Kett, Manuel C. Vallejo, et al. Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial.Anesth Analg 2020;131:1830–9.
Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial
BACKGROUND: In women undergoing cesarean delivery under spinal anesthesia with intrathecal morphine, transversus abdominis plane (TAP) block with bupivacaine hydrochloride (HCl) may not improve postsurgical analgesia. This lack of benefit could be related to the short duration of action of bupivacaine HCl. A retrospective study reported that TAP block with long-acting liposomal bupivacaine (LB) reduced opioid consumption and improved analgesia following cesarean delivery. Therefore, we performed a prospective multicenter, randomized, doubleblind trial examining efficacy and safety of TAP block with LB plus bupivacaine HCl versus bupivacaine HCl alone.
METHODS: Women (n = 186) with term pregnancies undergoing elective cesarean delivery under spinal anesthesia were randomized (1:1) to TAP block with LB 266 mg plus bupivacaine HCl 50 mg or bupivacaine HCl 50 mg alone. Efficacy was evaluated in a protocol-compliant analysis (PCA) set that was defined a priori. The primary end point was total postsurgical opioid consumption (oral morphine equivalent dosing [MED]) through 72 hours. Pain intensity was measured using a visual analog scale. Adverse events (AEs) after treatment were recorded through day 14.
RESULTS: Total opioid consumption through 72 hours was reduced with LB plus bupivacaine HCl versus bupivacaine HCl alone (least squares mean [LSM] [standard error (SE)] MED, 15.5 mg [6.67 mg] vs 32.0 mg [6.25 mg]). This corresponded to an LSM treatment difference of −16.5 mg (95% confidence interval [CI], −30.8 to −2.2 mg; P = .012). The area under the curve of imputed pain intensity scores through 72 hours supported noninferiority of LB plus bupivacaine HCl versus bupivacaine HCl alone (LSM [SE], 147.9 [21.13] vs 178.5 [19.78]; LSM treatment difference, −30.6; 95% CI, −75.9 to 14.7), with a prespecified noninferiority margin of 36 (P = .002). In an analysis of all treated patients, including those not meeting criteria for inclusion in the PCA, there was no difference in postsurgical opioid consumption
between groups. In the LB plus bupivacaine HCl group, 63.6% of patients experienced an AE after treatment versus 56.2% in the bupivacaine HCl–alone group. Serious AEs after treatment were rare (≈3% in both groups).
CONCLUSIONS: TAP block using LB plus bupivacaine HCl as part of a multimodal analgesia protocol incorporating intrathecal morphine resulted in reduced opioid consumption after cesarean delivery in the PCA set. Results suggest that with correct TAP block placement and adherence to a multimodal postsurgical analgesic regimen, there is an opioid-reducing benefit of adding LB to bupivacaine TAP blocks after cesarean delivery.
翻译：任文鑫 编辑：佟睿 审校：曹莹