NCT04821245已完成不适用
Defining Normal Postoperative Magnetic Resonance Imaging and Muscle Enzyme Levels After Total Knee Arthroplasty Associated With Continuous Adductor Canal Block
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Participants With Edema
研究概览
简要总结
The aim of this study was to describe the postoperative "baseline" magnetic resonance imaging (MRI) appearance of the ipsilateral thigh musculature after total knee arthroplasty (TKA). The secondary aim was to describe baseline muscle enzyme levels under the same clinical scenario. Neither of these measures have been reported previously.
详细描述
- In 2016, 3 sentinel cases of presumed local anesthetic-induced myotoxicity were reported after TKA with associated continuous adductor canal block (CACB) analgesia. The diagnosis was made based on its consistency with animal and human descriptions of local anesthetic myotoxicity, including: a) exposure to local anesthetic, b) delayed symptom onset after a period of normal recovery, c) rapid development of profound muscle flaccidity, and d) complete to partial recovery of motor function after weeks to months. MRIs obtained in these patients showed diffuse intra- and inter-muscular edema (inflammation) of the ipsilateral thigh, which was believed to support the presumptive diagnosis. However, because baseline MRI appearance of upper leg muscles has never been described for this clinical scenario, it is possible that the MRI scans represented "normal, baseline" appearance.
- This case series intended to prospectively describe postoperative MRI appearance in a cohort of asymptomatic volunteer patients that underwent uncomplicated TKA/CACB. In addition, because obtaining biomarkers of muscle injury might also be a reasonable diagnostic step, we sought to measure preoperative and postoperative creatine phosphokinase (CPK) and aldolase levels.
- MRI scans were read by 5 board-certified musculoskeletal radiologists masked to the study's purpose. Grading was done using a standard grid that facilitated systematic evaluation of various regions within the upper leg. At least 3 of 5 radiologists were required to declare edema as present within a given region of the leg.
- Only those volunteer patients that presented a normal postoperative course, i.e., had no unexpected leg muscle weakness, were entered into the study. As such, the MRI and muscle enzyme analysis results had no impact on the volunteer patients' clinical outcome or management. This was a prospective, observational/descriptive case series. There was no control group and we did not intend to investigate issues of cause-and-effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for unilateral primary TKA with CACB
- •TKA and early recovery was uncomplicated (no evidence of unexpected leg weakness)
排除标准
- •Contraindication to spinal anesthesia or adductor canal-based analgesia
- •History of muscle wasting or related disease
- •History of autoimmune disorders that may affect muscles
- •History of neurologic condition affecting the lower extremities
- •Contraindications to MRI
结局指标
主要结局
Number of Participants With Edema
时间窗: 1-2 days postoperative
Regions of the ipsilateral thigh were defined by muscle group, neuromuscular bundle, subcutaneous tissue, or inter-muscular fascial layers. Five board-certified musculoskeletal radiologists analyzed the scans for presence of edema. Edema was considered present if judged to be so by at least 3 of the 5 radiologists.
次要结局
- Postoperative Muscle Enzyme Levels(Sample was drawn the morning after surgery)
研究者
Joseph M. Neal
Affiliate Investigator
Benaroya Research Institute
研究点 (1)
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