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.

IF 3.3 2区 医学 Q1 CLINICAL NEUROLOGY
Pain and Therapy Pub Date : 2025-10-01 Epub Date: 2025-08-04 DOI:10.1007/s40122-025-00763-1
Lei Xie, Yazhi Xi, Xinyao He, Mingzi An, Xiaoyu Jia, Zhenping Li, Tao Chen, Qinghe Zhou
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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.

布比卡因脂质体与普通布比卡因联合地塞米松治疗胸腔镜术后疼痛的斜肋间阻滞:一项随机非效性试验。
有效和持续的术后镇痛是提高视频胸腔镜手术(VATS)后恢复的必要条件。布比卡因脂质体是一种多泡制剂,可延长局部麻醉释放时间,与传统药物相比具有机械优势。然而,先前与佐剂增强方案(如普通布比卡因加地塞米松)的比较因药理学和剂量不平等而混淆。这项等剂量随机对照试验评估了布比卡因脂质体通过肋间阻断(RIB)给药时是否比标准组合提供非劣效镇痛。方法:在本双盲随机对照试验中,90例VATS患者随机分为两组,一组为含有93 mg布比卡因脂质体和25 mg普通布比卡因的20 ml预混溶液(布比卡因脂质体组),另一组为含有105 mg普通布比卡因和5 mg地塞米松的20 ml混合物(普通布比卡因和地塞米松组)。评估的主要结果是48小时静息疼痛数值评定量表(NRS)的曲线下面积(AUC)。次要结局包括阿片类药物消耗、皮肤扩散和恢复质量-15评分(QoR-15)。结果:脂质体布比卡因不逊于普通布比卡因联合地塞米松,48小时NRS AUC分别为105.5±13.6和113.1±16.3(平均差- 7.6;95% CI - 13.9 ~ - 1.2,上限0.05)。两组在48和72 h持续皮区阻断方面有显著性差异(P < 0.05)。结论:布比卡因脂质体对VATS术后疼痛的镇痛效果与普通布比卡因联合地塞米松相似。试验注册:该试验已在ClinicalTrials.gov (NCT06392191)上注册。图形摘要可在本文的补充材料。
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来源期刊
Pain and Therapy
Pain and Therapy CLINICAL NEUROLOGY-
CiteScore
6.60
自引率
5.00%
发文量
110
审稿时长
6 weeks
期刊介绍: Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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