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Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03309644
Enrollment
1623
Registered
2017-10-13
Start date
2011-04-30
Completion date
2016-12-31
Last updated
2025-01-06

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

Conditions

Postoperative Complications

Keywords

Unplanned admissions, Visits to the ED, Readmissions, Death

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 Ottawa, Ontario.

Detailed description

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.

Interventions

Participants who receive a peripheral nerve block identified through the medical chart.

OTHERNo peripheral nerve blockade

Participants who did not receive a peripheral nerve block identified through the medical chart.

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
Healthy volunteers
Yes

Inclusion criteria

* Ontario residents * Aged 18 years and older * Elective ambulatory shoulder surgery

Exclusion criteria

* Emergency Surgery

Design outcomes

Primary

MeasureTime frameDescription
Postoperative ComplicationFrom day of surgery to 30 days after surgeryComposite 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.

Secondary

MeasureTime frameDescription
Health System Costs in the 30 Days After SurgeryFrom day of surgery to 30 days after surgeryCalculated using validated algorithms

Countries

Canada

Participant flow

Participants by arm

ArmCount
Peripheral Nerve Block
Peripheral nerve block Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart.
1,382
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.
241
Total1,623

Baseline characteristics

CharacteristicPeripheral Nerve BlockTotalNo Peripheral Nerve Block
Age, Continuous50.1 years
STANDARD_DEVIATION 15.4
49.7 years
STANDARD_DEVIATION 15.4
47.1 years
STANDARD_DEVIATION 15.4
American Society of Anesthesiology (ASA) Score
< 2
1054 Participants1237 Participants183 Participants
American Society of Anesthesiology (ASA) Score
> 2
328 Participants380 Participants52 Participants
Campus
Civic
143 Participants167 Participants24 Participants
Campus
General
487 Participants616 Participants129 Participants
Campus
Riverside
752 Participants840 Participants88 Participants
Elixhauser comorbidity index
0
1380 Participants1620 Participants240 Participants
Elixhauser comorbidity index
< 0
0 Participants0 Participants0 Participants
Elixhauser comorbidity index
1-5
0 Participants0 Participants0 Participants
Elixhauser comorbidity index
> 5
0 Participants0 Participants0 Participants
Elixhauser comorbidity index
Unable to report due to small cell size
2 Participants3 Participants1 Participants
Sex: Female, Male
Female
455 Participants541 Participants86 Participants
Sex: Female, Male
Male
927 Participants1082 Participants155 Participants
Surgery Location
Rotator cuff
528 Participants573 Participants45 Participants
Surgery Location
Shoulder joint
852 Participants1040 Participants188 Participants
Surgery Location
Shoulder muscle
2 Participants10 Participants8 Participants
Surgery type
Arthroscopic
1297 Participants1509 Participants212 Participants
Surgery type
Open
85 Participants114 Participants29 Participants
Year of Surgery
2011/12
517 Participants648 Participants131 Participants
Year of Surgery
2013/14
422 Participants496 Participants74 Participants
Year of Surgery
2015/16
443 Participants479 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,3820 / 241
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: From day of surgery to 30 days after surgery

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Peripheral Nerve BlockPostoperative ComplicationComposite outcome130 Participants
Peripheral Nerve BlockPostoperative ComplicationUnplanned admission20 Participants
Peripheral Nerve BlockPostoperative ComplicationReadmission within 30 days11 Participants
Peripheral Nerve BlockPostoperative ComplicationED visits within 30 days111 Participants
No Peripheral Nerve BlockPostoperative ComplicationED visits within 30 days11 Participants
No Peripheral Nerve BlockPostoperative ComplicationComposite outcome23 Participants
No Peripheral Nerve BlockPostoperative ComplicationReadmission within 30 days3 Participants
No Peripheral Nerve BlockPostoperative ComplicationUnplanned admission12 Participants
Secondary

Health System Costs in the 30 Days After Surgery

Calculated using validated algorithms

Time frame: From day of surgery to 30 days after surgery

ArmMeasureValue (MEDIAN)
Peripheral Nerve BlockHealth System Costs in the 30 Days After Surgery0 dollars
No Peripheral Nerve BlockHealth System Costs in the 30 Days After Surgery0 dollars

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026