Annals of medicine · 2026
Comparison of liposomal bupivacaine and bupivacaine hydrochloride intercostal nerve blocks for postoperative analgesia after thoracic surgery: a multicenter, randomized, three arms trial protocol.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Huang Junyi, Wang Lihua, Wei Shiyou, Xin Yuxuan, Chang Rui, Liu Hang, Yang Yiming, Song Jiong, Lv Xin
Аннотация
INTRODUCTION: Whether intercostal nerve block can fully realize the prolonged analgesic potential of liposomal bupivacaine remains uncertain. This study aims to evaluate whether liposomal bupivacaine administered via intercostal nerve block confers a long-acting analgesic advantage over bupivacaine hydrochloride and no block within the postoperative 25-72 h window.
PATIENTS AND METHODS: This is a multicenter, randomized, parallel, three-arm controlled trial planning to enroll 210 patients undergoing elective unilateral video-assisted thoracoscopic surgery. Using center-stratified block randomization (1:1:1), patients will be allocated at the end of surgery to receive an intercostal nerve block with liposomal bupivacaine, bupivacaine hydrochloride, or no block. All patients will follow a standardized general anesthesia and multimodal analgesia protocol. The primary outcome is the area under the curve for pain scores during the postoperative 25-72 h. Other outcomes include pain verbal response scale at predefined time points, cumulative postoperative morphine milligram equivalent consumption, sensory block recovery time, 15-item quality of recovery scale, postoperative nausea and vomiting, postoperative pulmonary complications, length of hospital stay.
DISCUSSION: This study prospectively evaluates the central question of whether liposomal bupivacaine confers a clinically meaningful long-acting analgesic advantage when used in the context of nerve block. By focusing on the area under the curve of pain scores and incorporating patient-centered outcomes such as opioid consumption and quality of recovery, the study aims to generate high-quality, translatable evidence to define the role of liposomal bupivacaine in thoracic surgery.
CLINICAL TRIAL REGISTRATION: Clinicaltrials.org, NCT07134660.
PATIENTS AND METHODS: This is a multicenter, randomized, parallel, three-arm controlled trial planning to enroll 210 patients undergoing elective unilateral video-assisted thoracoscopic surgery. Using center-stratified block randomization (1:1:1), patients will be allocated at the end of surgery to receive an intercostal nerve block with liposomal bupivacaine, bupivacaine hydrochloride, or no block. All patients will follow a standardized general anesthesia and multimodal analgesia protocol. The primary outcome is the area under the curve for pain scores during the postoperative 25-72 h. Other outcomes include pain verbal response scale at predefined time points, cumulative postoperative morphine milligram equivalent consumption, sensory block recovery time, 15-item quality of recovery scale, postoperative nausea and vomiting, postoperative pulmonary complications, length of hospital stay.
DISCUSSION: This study prospectively evaluates the central question of whether liposomal bupivacaine confers a clinically meaningful long-acting analgesic advantage when used in the context of nerve block. By focusing on the area under the curve of pain scores and incorporating patient-centered outcomes such as opioid consumption and quality of recovery, the study aims to generate high-quality, translatable evidence to define the role of liposomal bupivacaine in thoracic surgery.
CLINICAL TRIAL REGISTRATION: Clinicaltrials.org, NCT07134660.