Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty

Local Anesthetic Complication Clinical Trial

Official title:

Defining Normal Postoperative Magnetic Resonance Imaging and Muscle Enzyme Levels After Total Knee Arthroplasty Associated With Continuous Adductor Canal Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821245
• Other study ID #: BRI IRB18-008
• Status: Completed
• Start date: December 4, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: May 2021
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Local Anesthetic Complication
• Local Anesthetic Drug Adverse Reaction

Locations

Country	Name	City	State
United States	Benaroya Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Washington State Society of Anesthesiologists

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1-2 days postoperative
Secondary	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