Xu Mingzhe, He Yi, Li Zhi, Du Bin
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, China.
Trials. 2025 Jan 18;26(1):19. doi: 10.1186/s13063-025-08725-w.
Surgical intervention is critical in the treatment of hip developmental dysplasia in children. Perioperative analgesia, usually based on high opioid dosages, is frequently used in these patients. In some circumstances, regional anesthetic procedures such as caudal block and lumbar plexus block have also been used. Previous research has shown that pericapsular nerve group (PENG) block provides excellent anesthetic efficacy during open hip surgery in adults. PENG block is thought to provide a similar analgesia effect comparable to caudal block.
This study is a single-center, prospective, randomized, double-blinded, non-inferiority experiment that enrolled children aged 6 months to 7 years who were scheduled for developmental dysplasia hip surgery. Following general anesthesia and regional blocks (0.25% ropivacaine at a dose of 2.5 mg·kg with epinephrine at a concentration of 1:200,000), 48 individuals will be randomly assigned to either the PENG or caudal groups. The primary outcome measure is the highest FLACC (face, legs, activity, crying, consolability) score achieved within 24 h of surgery. Secondary outcomes include intraoperative opioid consumption, analgesic dosage within 24 h of surgery, time to start rescue analgesia, number of PCA pump activations, time to remove SLIPA (streamlined liner of the pharynx airway), duration of regional block procedures, incidence of adverse events, plasma ropivacaine concentrations, and hospital stays and costs. All data will be collected by blinded investigators. The trial's final results will be published in a peer-reviewed scientific journal.
We expect this trial to provide some evidences that PENG block is safe and effective for perioperative analgesia in pediatric patients undergoing open hip surgery.
Chinese Clinical Trial Registry ChiCTR2100053128. Registered on November 12, 2021.
手术干预在儿童髋关节发育不良的治疗中至关重要。这些患者通常采用基于高剂量阿片类药物的围手术期镇痛。在某些情况下，也会使用诸如骶管阻滞和腰丛阻滞等区域麻醉方法。先前的研究表明，关节囊周围神经群（PENG）阻滞在成人髋关节开放手术中具有出色的麻醉效果。PENG阻滞被认为能提供与骶管阻滞相当的镇痛效果。
本研究是一项单中心、前瞻性、随机、双盲、非劣效性试验，纳入了计划进行发育性髋关节发育不良手术的6个月至7岁儿童。在全身麻醉和区域阻滞（0.25%罗哌卡因，剂量为2.5mg·kg，肾上腺素浓度为1:200,000）后，48名个体将被随机分配至PENG组或骶管组。主要结局指标是术后24小时内达到的最高FLACC（面部、腿部、活动、哭闹、安慰性）评分。次要结局包括术中阿片类药物消耗量、术后24小时内的镇痛药物剂量、开始补救镇痛的时间、PCA泵启动次数、移除SLIPA（咽气道简化衬垫）的时间、区域阻滞操作持续时间、不良事件发生率、血浆罗哌卡因浓度以及住院时间和费用。所有数据将由盲法研究者收集。该试验的最终结果将发表在同行评审的科学期刊上。
我们期望本试验能提供一些证据，证明PENG阻滞在接受髋关节开放手术的儿科患者围手术期镇痛中是安全有效的。
中国临床试验注册中心ChiCTR2100053128。于2021年11月12日注册。
