止血带应用对全膝关节置换术后患者股四头肌形态和功能的影响：一项单盲随机对照试验的研究方案。
The effect of tourniquet application on the morphology and function of quadriceps in patients undergoing total knee arthroplasty: study protocol for a single-blind randomized controlled trial.
机构信息
Department of Orthopedics, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, China.
Engineering Research Center of Bone and Joint Precision Medicine, Ministry of Education, Beijing, China.
出版信息
Trials. 2022 Mar 5;23(1):201. doi: 10.1186/s13063-022-06114-1.
BACKGROUND
Tourniquet is currently widely used in total knee arthroplasty to reduce intraoperative blood loss. The academic view of tourniquet application in TKA is now in dispute. Some scholars argue that tourniquet may cause quadriceps injury and bring extra side effects, so they oppose the application of tourniquet. Others find that tourniquet application has no significant adverse impact on TKA patients. Regarding its advantages in reducing intraoperative blood loss, they advocate the regular application of tourniquet in TKA. Quadriceps injury is considered the main cause of tourniquet side effects. There are now many high-quality trials about tourniquet application in TKA but few of them concentrate on quadriceps morphology and function.
METHODS
A prospective, single-blind, randomized controlled trial will be adopted. The target sample is 130. Patients who meet the eligibility criteria will be randomly allocated to the tourniquet group and non-tourniquet group. The primary outcome is quadriceps thickness evaluated by ultrasound test. Secondary outcomes include quadriceps stiffness, rehabilitation outcomes, operation time, intraoperative and postoperative blood loss, blood transfusion rate, thigh circumference, VAS score, opioid consumption, D-dimer and C-reactive protein level in the serum, knee function score, postoperative satisfaction score, and complications.
DISCUSSION
This proposed study will contribute to improve evidence of tourniquet application in total knee arthroplasty. This will be a high-quality single-blind randomized controlled trial with a sufficient sample size and strict study design. It will investigate the effects of tourniquet application especially on the morphology and function of quadriceps in patients undergoing total knee arthroplasty and offer advice for tourniquet application in clinical practice.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR2000035097 . Registered on 31 July 2020.
背景
止血带目前广泛应用于全膝关节置换术，以减少术中失血量。止血带在 TKA 中的应用在学术界存在争议。一些学者认为止血带可能会导致股四头肌损伤，并带来额外的副作用，因此他们反对使用止血带。另一些人发现止血带的应用对 TKA 患者没有显著的不良影响。鉴于其在减少术中失血量方面的优势，他们主张在 TKA 中常规使用止血带。股四头肌损伤被认为是止血带副作用的主要原因。目前有许多关于 TKA 中止血带应用的高质量试验，但很少有试验集中在股四头肌形态和功能上。
方法
采用前瞻性、单盲、随机对照试验。目标样本量为 130 例。符合入选标准的患者将被随机分配到止血带组和非止血带组。主要结局指标是超声检查评估的股四头肌厚度。次要结局指标包括股四头肌僵硬、康复结局、手术时间、术中及术后失血量、输血率、大腿围度、VAS 评分、阿片类药物消耗、血清 D-二聚体和 C 反应蛋白水平、膝关节功能评分、术后满意度评分和并发症。
讨论
本研究将有助于提高止血带在全膝关节置换术中应用的证据水平。这将是一项高质量的单盲随机对照试验，样本量充足，研究设计严格。它将研究止血带应用对全膝关节置换术患者股四头肌形态和功能的影响，并为临床实践中的止血带应用提供建议。
试验注册
中国临床试验注册中心 ChiCTR2000035097 。注册于 2020 年 7 月 31 日。
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