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.
Lei Xie, Yazhi Xi, Xinyao He, Mingzi An, Xiaoyu Jia, Zhenping Li, Tao Chen, Qinghe Zhou
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引用次数: 0
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.
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.