Liposomal Bupivacaine vs. Plain Bupivacaine with Dexamethasone for Rhomboid Intercostal Block in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Non-inferiority Trial

脂质体布比卡因与普通布比卡因联合地塞米松用于胸腔镜辅助手术后疼痛管理的菱形肋间阻滞:一项随机非劣效性试验

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Abstract

INTRODUCTION: 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). METHODS: 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). RESULTS: 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). CONCLUSIONS: Rhomboid intercostal block with liposomal bupivacaine provided similar analgesia to plain bupivacaine with dexamethasone for postoperative pain after VATS. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (NCT06392191). Graphical Abstract available in the Supplementary Materials for this article.

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