Neuropathy Clinical Trial
Official title:
Detection and Prevention of Perioperative Nerve Injury Using Automated Somatosensory Evoked Potential Monitoring in Shoulder Arthroplasty Surgery
Verified date | December 2020 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Up to 5% of total shoulder arthroplasty patients experience transient or permanent nerve injury during surgery. In this study, we will monitor the nerve transmission of the patients' arm to detect whether the nerve is functioning normally. This techniques is called somatosensory evoked potential (SSEP) monitoring. In this study, we will assess whether SSEP monitoring could detect nerve abnormalities, alerts the surgical team enabling optimize their surgical intervention and prevent surgical related nerve injury.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 31, 2020 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult elective patients undergoing total shoulder arthroplasty surgery using general anesthesia Exclusion Criteria: - Patients unable to perform complete neurological examination - Patients who refuse to participate - Unable to obtain informed consent. - Patients who are contraindicated for (or unable to perform) SSEP monitoring - Patients who have known pre-existing peripheral neuropathy or brachial plexus injury - Patients who are contraindicated to brachial plexus block |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative duration of abnormal SSEP changes | The cumulative duration (min) of abnormal SSEP changes in the operative arm. | duration of surgery | |
Secondary | New-onset of peripheral neuropathy | New-onset peripheral neuropathy of the operative arm at postoperative 6 weeks. A thorough neurologic examination will be performed by an independent assessor before (after brachial plexus catheter inserted), and after the surgery (6 weeks). Any new neurological deficit at postoperative 6 weeks that identified by the independent outcomes assessor will be defined as a positive case. | 2 weeks, 6 weeks and 3 months | |
Secondary | American shoulder and elbow surgeons standardized shoulder assessment form | ASES score is a 100 point scale that consists of two dimensions; pain and daily activity. The pain scale is worth 50 points and the daily activity is worth 50 points. 100 points describes being pain- free and able to complete daily activity with no issues while a score of 0 describes extreme pain and unable to complete daily activities. | 2 weeks, 6 weeks and 3 months | |
Secondary | Quality of life measure | The EQ-5D-5L score consists of two components: a descriptive component to assess five dimensions of quality of life and an EQ visual analogue scale (VAS). The EQ-5D health state index is a single summary index, ranging from 0 to 1 (where 0 denotes death and 1 denotes full health/function), that is weighted to the country/region to describe the five dimensions of EQ-5D. | 2 weeks, 6 weeks and 3 months |
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