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

November 14, 2024 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

59644

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This will be a retrospective, population-based, cohort study based in Ontario, Canada. Our study population will include all Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery. The study period extends from April 2009 to March 2016.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Isolated General Anesthesia
No nerve block identified through physician billing codes
Other Names:
  • iGA
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.
Procedure: Peripheral Nerve Block
Nerve block identified through physician billing codes
Other Names:
  • PNB+GA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Death, Admission, Readmission or Emergency Department Visits
Time Frame: Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first
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
Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health System Costs
Time Frame: Date of surgery to 7 days and 30 days after surgery or death date, whichever came first
Costs in Canadian dollars will be calculated using standardized patient-level costing algorithms.
Date of surgery to 7 days and 30 days after surgery or death date, whichever came first
Neurology Consultations or Diagnostics
Time Frame: Date of surgery to 90 days after surgery or death date, whichever came first
Occurrence of neurology consult and/or nerve conduction study
Date of surgery to 90 days after surgery or death date, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Daniel McIsaac, MD, MPH, Department of Anesthesiology and Pain Medicine, University of Ottawa, Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2009

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMH2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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