An observational study in Local Anesthetic Complication and Local Anesthetic Drug Adverse Reaction, sponsored by Benaroya Research Institute. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Benaroya Research Institute · Observational
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.
437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.
This study's enrollment of 36 is below the median of 330 across 159 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →Benaroya Research Institute is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
Time frame: 1-2 days postoperative
Postoperative Muscle Enzyme Levels
Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal
Time frame: Sample was drawn the morning after surgery
* Tertiary care medical center * December 2018 through August 2019 * Potential volunteers were contacted by the principal investigator at least 24 hours prior to their surgery. Informed consent was obtained at this point. * Volunteers could decline to proceed at any point from initial informed consent through MRI scan or final blood draw
| Milestone | Single Cohort |
|---|---|
| Started | 36 |
| Completed | 27 |
| Not completed | 9 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Protocol violation | 5 |
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 | Participants Undergoing MRI |
|---|---|
| Number of Participants With Edema | 12 |
Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal
| Participants | CPK Analysis | Aldolase Analysis |
|---|---|---|
| Postoperative Muscle Enzyme Levels | 5 | 0 |
Collected over 10 days. Participant was evaluated at the time of the incident and twice during the 10 days thereafter.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MRI Appearance | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Event | MRI Appearance |
|---|---|
| Warmth around adductor canal catheter during MRIMusculoskeletal and connective tissue disorders | 1/13 |
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 62 (46 to 75) |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 18 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Overall Study |
|---|
| Weight(kg) | Overall Study |
|---|---|
| Mean | 89 (59 to 134) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified raw data in Excel format may be obtained from Joseph M. Neal, MD upon request.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Benaroya Research Institute