CompletedNCT03309644Updated Jan 6, 2025Results posted

Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

An observational study in Postoperative Complications, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Ottawa Hospital Research Institute · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 1,623
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Postoperative Complications

Browse trials for

Postoperative Complications 1,231

Keywords

Unplanned admissions
Visits to the ED
Readmissions
Death

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

This will be a retrospective, population-based, cohort study based in Ottawa, Ontario, Canada.

Inclusion criteria

Ontario residents
Aged 18 years and older
Elective ambulatory shoulder surgery

Exclusion criteria

Exclusion Criteria:

Emergency Surgery

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 1,623 participants (actual)
Patient registry: No

Groups and cohorts

Peripheral nerve block
Peripheral nerve block
Other: Peripheral nerve blockade
No peripheral nerve block
No peripheral nerve block
Other: No peripheral nerve blockade

Interventions

OtherPeripheral nerve blockade
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.

What researchers measure

Primary outcomes

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

Secondary outcomes

Health System Costs in the 30 Days After Surgery
Calculated using validated algorithms
Time frame: From day of surgery to 30 days after surgery

Results

Posted Jan 6, 2025

Limitations and caveats

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.

Participant flow

Participant flow — Overall Study
Milestone	Peripheral Nerve Block	No Peripheral Nerve Block
Started	1382	241
Completed	1382	241
Not completed	0	0

Outcome measures

PrimaryPostoperative 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
Reported as:: Count of participants · Participants

Postoperative Complication
Participants	Peripheral Nerve Block	No Peripheral Nerve Block
Composite outcome	130	23
Unplanned admission	20	12
Readmission within 30 days	11	3
ED visits within 30 days	111	11

SecondaryHealth System Costs in the 30 Days After Surgery

Calculated using validated algorithms

Time frame:: From day of surgery to 30 days after surgery
Reported as:: Median · dollars

Health System Costs in the 30 Days After Surgery
dollars	Peripheral Nerve Block	No Peripheral Nerve Block
Health System Costs in the 30 Days After Surgery	0 (0 to 0)	0 (0 to 0)

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Peripheral Nerve Block	0/1,382 (0%)	—	—
No Peripheral Nerve Block	0/241 (0%)	—	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
Mean	50.1 ± 15.4	47.1 ± 15.4	49.7 ± 15.4

Sex: Female, Male
Sex: Female, Male(Participants)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
Female	455	86	541
Male	927	155	1082

Year of Surgery
Year of Surgery(Participants)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
2011/12	517	131	648
2013/14	422	74	496
2015/16	443	36	479

Elixhauser comorbidity index
Elixhauser comorbidity index(Participants)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
< 0	0	0	0
0	1380	240	1620
1-5	0	0	0
> 5	0	0	0
Unable to report due to small cell size	2	1	3

Surgery Location
Surgery Location(Participants)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
Shoulder joint	852	188	1040
Rotator cuff	528	45	573
Shoulder muscle	2	8	10

American Society of Anesthesiology (ASA) Score
American Society of Anesthesiology (ASA) Score(Participants)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
< 2	1054	183	1237
> 2	328	52	380

Surgery type
Surgery type(Participants)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
Arthroscopic	1297	212	1509
Open	85	29	114

Campus
Campus(Participants)	Peripheral Nerve Block	No Peripheral Nerve Block	Total
Civic	143	24	167
General	487	129	616
Riverside	752	88	840

Study locations

1 site

Ottawa Hospital Research Institute
Ottawa, Ontario K1Y 4E9, Canada

References and documents

Publications

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. PubMed 30334192 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03309644
Lead sponsor: Ottawa Hospital Research Institute
Responsible party: Sponsor
First posted: Oct 13, 2017
Start date: Apr 2011
Primary completion: Dec 2016
Completion: Dec 2016
Results posted: Jan 6, 2025
Last update: Jan 6, 2025

Study contacts

Daniel I McIsaac, MD, MPH

principal investigator · Department of Anesthesiology and Pain Medicine, University of Ottawa

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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