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Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Shoulder Surgery

Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Ambulatory Shoulder Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03544775
Enrollment
59644
Registered
2018-06-04
Start date
2009-04-01
Completion date
2018-03-31
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Brief summary

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 Ontario.

Detailed description

First, investigators will validate health administrative data codes to demonstrate the accuracy of Ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (Ottawa Hospital Data Warehouse data). Then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.

Interventions

PROCEDUREIsolated General Anesthesia

No nerve block identified through physician billing codes

PROCEDUREPeripheral Nerve Block

Nerve block identified through physician billing codes

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Ontario residents * Aged 18 years and older * Elective ambulatory shoulder surgery performed in Ontario between April 2009 and December 2016.

Exclusion criteria

* Emergency Surgery * If a patient undergoes multiple elective shoulder surgeries within the time period, only the first surgery will be included for any participant in the study period.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Death, Admission, Readmission or Emergency Department VisitsDate of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came firstComposite outcome of: 1) unplanned admissions on the day of surgery , 2) post-discharge emergency department visits within 7 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause

Secondary

MeasureTime frameDescription
Health System CostsDate of surgery to 7 days and 30 days after surgery or death date, whichever came firstCosts in Canadian dollars will be calculated using standardized patient-level costing algorithms.
Neurology Consultations or DiagnosticsDate of surgery to 90 days after surgery or death date, whichever came firstOccurrence of neurology consult and/or nerve conduction study

Participant flow

Participants by arm

ArmCount
Isolated General Anesthesia
Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes. Isolated General Anesthesia: No nerve block identified through physician billing codes
28,571
Peripheral Nerve Block
Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. Peripheral Nerve Block: Nerve block identified through physician billing codes
31,073
Total59,644

Baseline characteristics

CharacteristicIsolated General AnesthesiaPeripheral Nerve BlockTotal
Age, Continuous51 years
STANDARD_DEVIATION 13
52 years
STANDARD_DEVIATION 12
51 years
STANDARD_DEVIATION 12
Healthcare resource use
Emergency department visit in the last year
12543 Participants12181 Participants24724 Participants
Healthcare resource use
Hospitalization in the last year
1657 Participants1523 Participants3180 Participants
Neighbourhood Income Quintile3 Neighbourhood income quintile3 Neighbourhood income quintile3 Neighbourhood income quintile
Rural5343 Participants4039 Participants9382 Participants
Sex: Female, Male
Female
9343 Participants10534 Participants19877 Participants
Sex: Female, Male
Male
19228 Participants20539 Participants39767 Participants
Surgery Type
Arthroscopic
20314 Participants23584 Participants43898 Participants
Surgery Type
Open
8257 Participants7489 Participants15746 Participants
Surgery Type
Other shoulder repair
343 Participants124 Participants467 Participants
Surgery Type
Rotator cuff repair
16571 Participants19607 Participants36178 Participants
Surgery Type
Shoulder arthroplasty or joint repair
11657 Participants11342 Participants22999 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Postoperative Death, Admission, Readmission or Emergency Department Visits

Composite outcome of: 1) unplanned admissions on the day of surgery , 2) post-discharge emergency department visits within 7 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause

Time frame: Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first

Population: Primary analysis

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Isolated General AnesthesiaPostoperative Death, Admission, Readmission or Emergency Department VisitsUnplanned admission1,784 Participants
Isolated General AnesthesiaPostoperative Death, Admission, Readmission or Emergency Department VisitsReadmission within 30 days85 Participants
Isolated General AnesthesiaPostoperative Death, Admission, Readmission or Emergency Department VisitsED visits within 7 days1,779 Participants
Isolated General AnesthesiaPostoperative Death, Admission, Readmission or Emergency Department VisitsComposite outcome3,424 Participants
Peripheral Nerve BlockPostoperative Death, Admission, Readmission or Emergency Department VisitsComposite outcome2,808 Participants
Peripheral Nerve BlockPostoperative Death, Admission, Readmission or Emergency Department VisitsUnplanned admission1,132 Participants
Peripheral Nerve BlockPostoperative Death, Admission, Readmission or Emergency Department VisitsED visits within 7 days1,732 Participants
Peripheral Nerve BlockPostoperative Death, Admission, Readmission or Emergency Department VisitsReadmission within 30 days98 Participants
Secondary

Health System Costs

Costs in Canadian dollars will be calculated using standardized patient-level costing algorithms.

Time frame: Date of surgery to 7 days and 30 days after surgery or death date, whichever came first

ArmMeasureGroupValue (MEAN)
Isolated General AnesthesiaHealth System CostsCost after surgery (7 days)4,391 Canadian Dollars
Isolated General AnesthesiaHealth System CostsCost after surgery (30 days)4528 Canadian Dollars
Peripheral Nerve BlockHealth System CostsCost after surgery (7 days)4681 Canadian Dollars
Peripheral Nerve BlockHealth System CostsCost after surgery (30 days)4840 Canadian Dollars
Secondary

Neurology Consultations or Diagnostics

Occurrence of neurology consult and/or nerve conduction study

Time frame: Date of surgery to 90 days after surgery or death date, whichever came first

ArmMeasureGroupValue (MEAN)Dispersion
Isolated General AnesthesiaNeurology Consultations or DiagnosticsNerve conduction studies in the 90 days after surgery235 VisitsStandard Deviation 0.8
Isolated General AnesthesiaNeurology Consultations or DiagnosticsNeurology consultations in the 90 days after surgery74 VisitsStandard Deviation 0.3
Peripheral Nerve BlockNeurology Consultations or DiagnosticsNeurology consultations in the 90 days after surgery92 VisitsStandard Deviation 0.3
Peripheral Nerve BlockNeurology Consultations or DiagnosticsNerve conduction studies in the 90 days after surgery274 VisitsStandard Deviation 0.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026