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This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ottawa, Ontario.
The investigators will use a coarsened exact matching algorithm prior to the analysis to minimize bias in this observational study. A multivariate logistic regression model will be used to compare the effect of anesthesia interventions on the primary outcome within matched cohorts. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral nerve block | Peripheral nerve block |
| |
| No peripheral nerve block | No peripheral nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral nerve blockade | Other | Participants who receive a peripheral nerve block identified through the medical chart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complication | Composite outcome: 1) unplanned admissions on the day of surgery, 2) post-discharge ED visits within 30 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause. | From day of surgery to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Health System Costs in the 30 Days After Surgery | Calculated using validated algorithms | From day of surgery to 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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This will be a retrospective, population-based, cohort study based in Ottawa, Ontario, Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I McIsaac, MD, MPH | Department of Anesthesiology and Pain Medicine, University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30334192 | Derived | Hamilton GM, Ramlogan R, Lui A, McCartney CJL, Abdallah F, McIsaac DI. Association of peripheral nerve blocks with postoperative outcomes in ambulatory shoulder surgery patients: a single-centre matched-cohort study. Can J Anaesth. 2019 Jan;66(1):63-74. doi: 10.1007/s12630-018-1234-8. Epub 2018 Oct 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peripheral Nerve Block | Peripheral nerve block Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart. |
| FG001 | No Peripheral Nerve Block | No peripheral nerve block No peripheral nerve blockade: Participants who did not receive a peripheral nerve block identified through the medical chart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peripheral Nerve Block | Peripheral nerve block Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart. |
| BG001 | No Peripheral Nerve Block |
| 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 | Postoperative Complication | Composite outcome: 1) unplanned admissions on the day of surgery, 2) post-discharge ED visits within 30 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause. | Posted | Count of Participants | Participants | From day of surgery to 30 days after surgery |
|
1 year
All-Cause Mortality was collected including all deaths both anticipated and unanticipated due to any cause. Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Peripheral Nerve Block | Peripheral nerve block Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart. |
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There is risk of exposure misclassification bias. Confounding bias may have influenced the receipt of specific anesthesia interventions and outcomes. This study did not examine longer-term outcomes. We do not have data that specifically link the anesthesiologist or surgeon to the patient. This study examines data obtained from a single academic health sciences centre. Given the unexpected lower rates of adverse events in our institution, results may be due to this study being underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel McIsaac | The Ottawa Hospital | 613-761-4940 | dmcisaac@toh.ca |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| No peripheral nerve blockade | Other | Participants who did not receive a peripheral nerve block identified through the medical chart. |
|
No peripheral nerve block
No peripheral nerve blockade: Participants who did not receive a peripheral nerve block identified through the medical chart.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Year of Surgery | Count of Participants | Participants |
|
| Elixhauser comorbidity index | The Elixhauser Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis codes. Each comorbidity category is documented as disease presence or disease absence and there are 31 categories. Therefore, a higher score indicates more presence of disease (with 31 being the maximum). | Count of Participants | Participants |
|
| Surgery Location | Count of Participants | Participants |
|
| American Society of Anesthesiology (ASA) Score | Physical status classification used to determine a patient's risk with anaesthesia. The score ranges from I to VI, with I indicating a healthy person and VI indicating a deceased organ donor. A higher score indicates greater risk. | Six missing values for ASA score, all from the 'No PNB' group | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
| Campus | Count of Participants | Participants |
|
|
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| Secondary | Health System Costs in the 30 Days After Surgery | Calculated using validated algorithms | Posted | Median | Inter-Quartile Range | dollars | From day of surgery to 30 days after surgery |
|
|
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| 0 |
| 1,382 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Peripheral Nerve Block | No peripheral nerve block No peripheral nerve blockade: Participants who did not receive a peripheral nerve block identified through the medical chart. | 0 | 241 | 0 | 0 | 0 | 0 |
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