Effect of preoperative liposomal bupivacaine single-injection pericapsular nerve group (PENG) block on lower extremity deep vein thrombosis in elderly patients with hip fractures: a randomised controlled, double-blind, prospective clinical study protocol

术前单次注射脂质体布比卡因关节囊周围神经阻滞(PENG阻滞)对老年髋部骨折患者下肢深静脉血栓形成的影响:一项随机、双盲、前瞻性临床研究方案

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Abstract

INTRODUCTION: Deep vein thrombosis (DVT) of the lower limbs has a significantly higher incidence among elderly populations than that observed in other types of fractures, prolonged immobilisation and the systemic inflammatory response triggered by preoperative pain are the main risk factors. Liposomal bupivacaine (LB) single-injection pericapsular nerve group (PENG) block has demonstrated effective analgesia both before and after surgery, while preserving motor function in patients with hip fracture. Although regional nerve block is a well-established component of preoperative multimodal analgesia, its potential role and underlying mechanisms in the prevention of DVT in elderly patients with hip fracture remain largely unexplored. METHODS AND ANALYSIS: This study will be conducted as a double-blind, randomised, sham-controlled, prospective clinical trial. On admission, a total of 132 participants will be randomly assigned using block randomisation to receive either treatment group (LB single-injection PENG block) or sham group (saline solution single-injection PENG block). The primary outcome was the incidence of DVT, while secondary outcomes included perioperative inflammatory and immune-related stress levels and functional-based pain scores. ETHICS AND DISSEMINATION: This study protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines and has been approved by the Ethics Committee of Shunde Hospital, Guangzhou University of Traditional Chinese Medicine (Approval No KY-2025005). The raw data are planned to be made publicly available on the ResMan raw data-sharing platform (IPD sharing platform) of the Chinese Clinical Trial Registry in December 2027 and can be accessed at http://www.medresman.org.cn. TRIAL REGISTRATION NUMBER: ChiCTR2500100799.

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