Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty

NCT ID: NCT04821245

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2019-08-02

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.

Conditions

Local Anesthetic Complication; Local Anesthetic Drug Adverse Reaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington State Society of Anesthesiologists

OTHER

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph M. Neal

Affiliate Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph M Neal, MD

Role: PRINCIPAL_INVESTIGATOR

Benaroya Research Center at Virginia Mason Medical Center

Locations

Benaroya Research Institute

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27662067 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28419048 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30236244 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34059556 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: w/o statistical comment

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan (specific comment)

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Document Type: Informed Consent Form

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Other Identifiers

BRI IRB18-008

Identifier Type: -

Identifier Source: org_study_id