Xie Lei, Xi Yazhi, He Xinyao, An Mingzi, Jia Xiaoyu, Li Zhenping, Chen Tao, Zhou Qinghe
Anesthesia Medicine, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Department of Anesthesiology and Pain Medicine, The Affiliated Hospital of Jiaxing University, No. 1882, South of the Second Ring Road, Jiaxing, Zhejiang, China.
Pain Ther. 2025 Aug 4. doi: 10.1007/s40122-025-00763-1.
Effective and sustained postoperative analgesia is essential to enhance recovery after video-assisted thoracoscopic surgery (VATS). Liposomal bupivacaine, a multivesicular formulation enabling extended local anesthetic release, offers a mechanistic advantage over conventional agents. However, prior comparisons with adjuvant-enhanced regimens such as plain bupivacaine plus dexamethasone were confounded by pharmacological and dose inequivalence. This equivalence-dose randomized controlled trial evaluated whether liposomal bupivacaine provides non-inferior analgesia to the standard combination when administered via rhomboid intercostal block (RIB).
In this double-blind randomized controlled trial, 90 VATS patients were randomly assigned to receive either: a 20-ml premixed solution containing 93 mg of liposomal bupivacaine combined with 25 mg of plain bupivacaine (liposomal bupivacaine group), or a 20-ml admixture of 105 mg of plain bupivacaine and 5 mg of dexamethasone (plain bupivacaine with dexamethasone group). The primary outcome assessed was the area under the curve (AUC) of the 48-h resting pain numeric rating scale (NRS). Secondary outcomes consisted of opioid consumption, dermatomal spread, and Quality of Recovery-15 scores (QoR-15).
Liposomal bupivacaine was shown to be non-inferior to plain bupivacaine with dexamethasone, with a 48-h NRS AUC of 105.5 ± 13.6 vs. 113.1 ± 16.3 (mean difference - 7.6; 95% CI - 13.9 to - 1.2, upper limit < non-inferiority margin 3.7). Opioid use and dermatomal spread were comparable within the first 24 h (P > 0.05). There was a notable contrast in sustained dermatome blockade at 48 and 72 h between the two groups (P < 0.001). The liposomal bupivacaine group demonstrated a significantly reduced opioid requirement (P = 0.016) within 24-48 h and superior QoR-15 scores on postoperative day 2 (POD2) (P < 0.001). Safety profiles were comparable, with no between-group differences in postoperative nausea and vomiting or other severe complications (P > 0.05).
Rhomboid intercostal block with liposomal bupivacaine provided similar analgesia to plain bupivacaine with dexamethasone for postoperative pain after VATS.
The trial was registered on ClinicalTrials.gov (NCT06392191). Graphical Abstract available in the Supplementary Materials for this article.
有效的持续术后镇痛对于促进电视辅助胸腔镜手术（VATS）后的恢复至关重要。脂质体布比卡因是一种能够实现局部麻醉药延长释放的多泡制剂，与传统药物相比具有机制上的优势。然而，先前与辅助增强方案（如普通布比卡因加地塞米松）的比较因药理学和剂量不等效而受到混淆。这项等效剂量随机对照试验评估了通过菱形肋间阻滞（RIB）给药时，脂质体布比卡因是否能提供不劣于标准组合的镇痛效果。
在这项双盲随机对照试验中，90例VATS患者被随机分配接受以下两种治疗之一：一种20毫升预混溶液，含有93毫克脂质体布比卡因和25毫克普通布比卡因（脂质体布比卡因组）；或一种20毫升的混合物，含有105毫克普通布比卡因和5毫克地塞米松（普通布比卡因加地塞米松组）。评估的主要结局是48小时静息疼痛数字评分量表（NRS）的曲线下面积（AUC）。次要结局包括阿片类药物消耗量、皮节扩散和恢复质量-15评分（QoR-15）。
脂质体布比卡因被证明不劣于普通布比卡因加地塞米松，48小时NRS AUC为105.5±13.6，而普通布比卡因加地塞米松组为113.1±16.3（平均差异-7.6；95%置信区间-13.9至-1.2，上限<非劣效界值3.7）。在前24小时内，阿片类药物使用和皮节扩散相当（P>0.05）。两组在48小时和72小时的持续皮节阻滞方面存在显著差异（P<0.001）。脂质体布比卡因组在24至48小时内阿片类药物需求量显著降低（P=0.016），且术后第2天（POD2）的QoR-15评分更高（P<0.001）。安全性相当，术后恶心呕吐或其他严重并发症在组间无差异（P>0.05）。
脂质体布比卡因菱形肋间阻滞为VATS术后疼痛提供了与普通布比卡因加地塞米松相似的镇痛效果。
该试验在ClinicalTrials.gov上注册（NCT06392191）。本文补充材料中有图形摘要。
