联合神经阻滞麻醉对老年全髋关节置换术中应激及置换后免疫功能的影响:随机对照临床试验方案  

Effects of a combined nerve block on intraoperative stress and postoperative immune function in elderly patients subjected to total hip replacement:study protocol for a randomized controlled trial

作　　者：阿良德[1] 张广元[2] 闫红秀[3] 郭延洪 袁永瑾 贾珍[1] 

机构地区：[1]青海大学附属医院麻醉科,青海省西宁市810001 [2]青海大学附属医院关节科,青海省西宁市810001 [3]青海大学附属医院疼痛科,青海省西宁市810001

出　　处：《中国组织工程研究》2016年第39期5892-5897,共6页Chinese Journal of Tissue Engineering Research

摘　　要：背景:麻醉和手术等伤害性刺激对老年全髋关节置换术中应激反应和血流变指标的影响较为明显,容易使患者自身的生理机能受干扰,置换后免疫功能下降,影响置换后的髋关节功能恢复。以往老年患者行髋关节置换的麻醉方式主要为全身麻醉,腰椎穿刺麻醉及硬膜外麻醉等单一麻醉方法。以往有研究表明,老年全髋关节置换患者更适合采用联合神经阻滞麻醉,更安全可靠。目的:观察联合神经阻滞麻醉对老年全髋关节置换术中应激及置换后免疫功能的影响。方法:研究为前瞻性、单中心、随机对照、开放性临床试验,在中国青海,青海大学附属医院完成。将纳入试验的老年全髋关节置换患者120例随机分为2组,每组60例,试验组术中采取联合神经阻滞麻醉,包括下肢腰丛、坐骨神经、L1-2椎旁神经联合阻滞麻醉,对照组术中采用全身麻醉,随访3个月。试验的主要观察指标为术中患者血清皮质醇浓度评价术中应激反应情况;次要观察指标为麻醉前、术前,置换后即刻血清皮质醇浓度,以及麻醉前、术前,术中、置换后即刻血糖浓度评价患者各时间段的应激反应情况;免疫功能相关指标包括麻醉前,置换后即刻,置换后1,3,7 d及3个月患者白细胞、中性粒细胞绝对值、白细胞介素1,6、肿瘤坏死因子α、T淋巴细胞亚群水平,评价患者置换后的免疫功能;血流动力学指标包括麻醉前,术中,置换后即刻心电图,脉搏,收缩压、舒张压、心率、血气分析检测结果,观察患者血液相关参数的变化;置换后1,3,7 d及3个月不良事件发生率,以评价患者置换后的并发症发生情况。试验经中国青海大学附属医院医学伦理委员会批准(审批号:QHY1017D)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者对试验内容和治疗过程均知情同意,并签署知情同意书。讨论:试验比较联合神经阻滞麻醉及�BACKGROUND： Anesthesia, surgery, and other nociceptive stimuli affect stress and hemorheological indices, impact physiological function, decrease immune function, and thereby influence recovery of hip joint function in elderly patients who undergo total hip replacement. Previous anesthesia methods for hip replacement in elderly patients include general, lumbar puncture, or epidural anesthesia alone. A combined nerve block is more suitable for total hip replacement in the elderly because of the safety and reliability of the method. In this study, we hypothesized that a combined nerve block is superior to any previous anesthesia method alone for total hip replacement in the elderly. Specifically, we hypothesized that intraoperative stress, hemorheological indices, postoperative immune function, and incidence of postoperative complications would be more favorable using a combined nerve block compared with previous anesthesia methods. OBJECTIVE： To investigate the effects of a combined nerve block on intraoperative stress and postoperative immune function in elderly patients subjected to total hip replacement. METHODS： This is a prospective, single-center, randomized controlled, open-label trial, which will be performed at Qingdao University Affiliated Hospital, China. A total of 120 elderly patients scheduled to undergo total hip replacement will be randomly assigned to undergo a combined nerve block（involving lower lumbar plexus, sciatic nerve, and paraspinal nerve L1-2）（experimental group, n=60）, or general anesthesia（control group, n=60）. All patients will be followed up for 3 months. The primary outcome will be serum cortisol concentration during surgery, as a measure of intraoperative stress. Secondary outcomes include serum cortisol concentration prior to anesthesia, and prior to and immediately after surgery; blood glucose level prior to anesthesia, and prior to, during, and after surgery, used to evaluate stress during different times. In addition, immune function-related indices including

关 键 词：组织工程 髋关节 手术后并发症 血糖 骨科植入物 人工假体 髋关节置换 联合神经阻滞麻醉 全身麻醉 老年 应激 免疫功能 皮质醇 并发症 随机对照临床试验 

分 类 号：R318[医药卫生—生物医学工程]