Local Anesthetic Complication, Local Anesthetic Drug Adverse Reaction
Conditions
Keywords
Myotoxicity, Myositis, Magnetic resonance imaging, Creatine phosphokinase, Aldolase
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.
Interventions
None listed
Sponsors
Washington State Society of Anesthesiologists
Benaroya Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Edema | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Muscle Enzyme Levels | Sample was drawn the morning after surgery | Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal |
Countries
United States
Participant flow
Recruitment details
* 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
Pre-assignment details
-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
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All enrolled subjects | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 62 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Weight | 89 kg | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 1 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: 1-2 days postoperative
Population: Participants that underwent postoperative MRI scan of operated leg
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Undergoing MRI | Number of Participants With Edema | 12 participants |
Secondary
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
Population: Participants with CPK levels 12% to 111%, and aldolase levels, in excess of high normal values
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Undergoing MRI | Postoperative Muscle Enzyme Levels | 5 Participants |
| Aldolase Analysis | Postoperative Muscle Enzyme Levels | 0 Participants |