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| Name | Class |
|---|---|
| Washington State Society of Anesthesiologists | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Edema | 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. | 1-2 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Muscle Enzyme Levels | Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal | Sample was drawn the morning after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M Neal, MD | Benaroya Research Center at Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benaroya Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27662067 | Background | 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. | |
| 28419048 | Background | 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. |
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De-identified raw data in Excel format may be obtained from Joseph M. Neal, MD upon request.
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March 2021 through March 2026
Upon request
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-Volunteer patients only entered the study if they showed no signs of unexpected ipsilateral upper leg weakness prior to drawing blood samples or obtaining MRI scans
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Cohort | All volunteer patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All enrolled subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Edema | 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. | Participants that underwent postoperative MRI scan of operated leg | Posted | Number | participants | 1-2 days postoperative |
|
|
10 days. Participant was evaluated at the time of the incident and twice during the 10 days thereafter.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI Appearance | Volunteers undergoing MRI examination | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Warmth around adductor canal catheter during MRI | Musculoskeletal and connective tissue disorders | Systematic Assessment | As described above - mild, vague warmth around catheter at start of MRI, which was subsequently cancelled. The warmth resolved quickly and the patient was not harmed. |
This case series aimed to describe MRI appearance and muscle enzyme levels presented under the same clinical conditions as the 3 sentinel cases of presumed local anesthetic myotoxicity after TKA/CACB. This descriptive design was not intended to sort cause-and-effect (that is, the relative role of surgery, pneumatic tourniquet, local anesthetic, etc.) in causing muscular edema or raising enzyme levels.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph M. Neal, MD | Benaroya Research Institute | 206-223-6980 | Joseph.Neal@virginiamason.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: w/o statistical comment | Apr 13, 2018 | Mar 28, 2021 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan (specific comment) | Apr 9, 2018 | May 3, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2019 | Mar 28, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000081030 | Myotoxicity |
| D009220 | Myositis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| 30236244 | Background | 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. |
| 34059556 | Derived | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Weight | Mean | Full Range | kg |
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| Participants |
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| Secondary | Postoperative Muscle Enzyme Levels | Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal | Participants with CPK levels 12% to 111%, and aldolase levels, in excess of high normal values | Posted | Count of Participants | Participants | No | Sample was drawn the morning after surgery |
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| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |