Trial Outcomes & Findings for Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Shoulder Surgery (NCT NCT03544775)
NCT ID: NCT03544775
Last Updated: 2024-11-27
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
59644 participants
Primary outcome timeframe
Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first
Results posted on
2024-11-27
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
28571
|
31073
|
|
Overall Study
COMPLETED
|
28571
|
31073
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Shoulder Surgery
Baseline characteristics by cohort
| Measure |
Isolated General Anesthesia
n=28571 Participants
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
|
Peripheral Nerve Block
n=31073 Participants
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
|
Total
n=59644 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 13 • n=5 Participants
|
52 years
STANDARD_DEVIATION 12 • n=7 Participants
|
51 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9343 Participants
n=5 Participants
|
10534 Participants
n=7 Participants
|
19877 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19228 Participants
n=5 Participants
|
20539 Participants
n=7 Participants
|
39767 Participants
n=5 Participants
|
|
Surgery Type
Shoulder arthroplasty or joint repair
|
11657 Participants
n=5 Participants
|
11342 Participants
n=7 Participants
|
22999 Participants
n=5 Participants
|
|
Surgery Type
Rotator cuff repair
|
16571 Participants
n=5 Participants
|
19607 Participants
n=7 Participants
|
36178 Participants
n=5 Participants
|
|
Surgery Type
Other shoulder repair
|
343 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
|
Surgery Type
Arthroscopic
|
20314 Participants
n=5 Participants
|
23584 Participants
n=7 Participants
|
43898 Participants
n=5 Participants
|
|
Surgery Type
Open
|
8257 Participants
n=5 Participants
|
7489 Participants
n=7 Participants
|
15746 Participants
n=5 Participants
|
|
Neighbourhood Income Quintile
|
3 Neighbourhood income quintile
n=5 Participants
|
3 Neighbourhood income quintile
n=7 Participants
|
3 Neighbourhood income quintile
n=5 Participants
|
|
Rural
|
5343 Participants
n=5 Participants
|
4039 Participants
n=7 Participants
|
9382 Participants
n=5 Participants
|
|
Healthcare resource use
Hospitalization in the last year
|
1657 Participants
n=5 Participants
|
1523 Participants
n=7 Participants
|
3180 Participants
n=5 Participants
|
|
Healthcare resource use
Emergency department visit in the last year
|
12543 Participants
n=5 Participants
|
12181 Participants
n=7 Participants
|
24724 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came firstPopulation: Primary analysis
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
Outcome measures
| Measure |
Isolated General Anesthesia
n=28571 Participants
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
|
Peripheral Nerve Block
n=31073 Participants
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
|
|---|---|---|
|
Postoperative Death, Admission, Readmission or Emergency Department Visits
Unplanned admission
|
1,784 Participants
|
1,132 Participants
|
|
Postoperative Death, Admission, Readmission or Emergency Department Visits
Readmission within 30 days
|
85 Participants
|
98 Participants
|
|
Postoperative Death, Admission, Readmission or Emergency Department Visits
ED visits within 7 days
|
1,779 Participants
|
1,732 Participants
|
|
Postoperative Death, Admission, Readmission or Emergency Department Visits
Composite outcome
|
3,424 Participants
|
2,808 Participants
|
SECONDARY outcome
Timeframe: Date 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.
Outcome measures
| Measure |
Isolated General Anesthesia
n=28571 Participants
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
|
Peripheral Nerve Block
n=31073 Participants
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
|
|---|---|---|
|
Health System Costs
Cost after surgery (7 days)
|
4,391 Canadian Dollars
Interval 3910.0 to 4836.0
|
4681 Canadian Dollars
Interval 4337.0 to 5066.0
|
|
Health System Costs
Cost after surgery (30 days)
|
4528 Canadian Dollars
Interval 4014.0 to 5019.0
|
4840 Canadian Dollars
Interval 4451.0 to 5258.0
|
SECONDARY outcome
Timeframe: Date of surgery to 90 days after surgery or death date, whichever came firstOccurrence of neurology consult and/or nerve conduction study
Outcome measures
| Measure |
Isolated General Anesthesia
n=28 Participants
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
|
Peripheral Nerve Block
n=31 Participants
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
|
|---|---|---|
|
Neurology Consultations or Diagnostics
Neurology consultations in the 90 days after surgery
|
74 Visits
Standard Deviation 0.3
|
92 Visits
Standard Deviation 0.3
|
|
Neurology Consultations or Diagnostics
Nerve conduction studies in the 90 days after surgery
|
235 Visits
Standard Deviation 0.8
|
274 Visits
Standard Deviation 0.9
|
Adverse Events
Isolated General Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peripheral Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place