Clinical trial NCT04821245: Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty
Official title: Defining Normal Postoperative Magnetic Resonance Imaging and Muscle Enzyme Levels After Total Knee Arthroplasty Associated With Continuous Adductor Canal Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Local Anesthetic Complication
Local Anesthetic Drug Adverse Reaction
Keywords: Myotoxicity
Myositis
Magnetic resonance imaging
Creatine phosphokinase
Aldolase
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Washington State Society of Anesthesiologists
First posted: 2021-03-29
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Volunteer patients of various age and sex
* Number of volunteers and diagnostic studies determined by available grant monies
* Volunteers were drawn from a population presenting for unilateral primary TKA performed by 1 of 2 orthopedic surgeons in a single institution

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral primary TKA with CACB
* TKA and early recovery was uncomplicated (no evidence of unexpected leg weakness)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Edema
timeFrame: 1-2 days postoperative
Secondary outcomes:
measure: Postoperative Muscle Enzyme Levels
timeFrame: Sample was drawn the morning after surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Benaroya Research Institute
state: Washington
Study officials:
affiliation: Benaroya Research Center at Virginia Mason Medical Center
name: Joseph M Neal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neal JM, Salinas FV, Choi DS. Local Anesthetic-Induced Myotoxicity After Continuous Adductor Canal Block. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):723-727. doi: 10.1097/AAP.0000000000000466.
citation: Neal JM, Salinas FV, Choi DS. Reply to Dr Kelly et al. Reg Anesth Pain Med. 2017 May/Jun;42(3):414. doi: 10.1097/AAP.0000000000000574. No abstract available.
citation: Hussain N, McCartney CJL, Neal JM, Chippor J, Banfield L, Abdallah FW. Local anaesthetic-induced myotoxicity in regional anaesthesia: a systematic review and empirical analysis. Br J Anaesth. 2018 Oct;121(4):822-841. doi: 10.1016/j.bja.2018.05.076. Epub 2018 Aug 8.
citation: Mahyar L, Neal JM, Blackmore CC, Jackson DW, Hanson NA, MacDonald KM, Warren D, Verdin PJ. MRI and muscle enzymes do not support the diagnosis of local anesthetic myotoxicity: a descriptive case series. Reg Anesth Pain Med. 2021 Aug;46(8):679-682. doi: 10.1136/rapm-2021-102772. Epub 2021 May 31.