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

NCT03544775 | Completed Results

• 1 other identifier: GMH2
• Study Type: observational
• Target: 59,644
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (2)

• Health System Costs

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

• Neurology Consultations or Diagnostics

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

Study Arms (2)

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

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

Interventions

Isolated General Anesthesia PROCEDURE

No nerve block identified through physician billing codes

Also known as: iGA

Isolated General Anesthesia

Peripheral Nerve Block PROCEDURE

Nerve block identified through physician billing codes

Also known as: PNB+GA

Peripheral Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Postoperative Complications

Interventions

Immunoglobulin A

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

There is risk of misclassification bias. Confounding bias may influence receipt of specific interventions and outcomes. We were unable to measure patient-reported outcomes. Cost were captured at the health system level, but were not adequately granular to capture operating room supplies. We did not have specifics of each nerve block technique that may impact nerve block.

Results Point of Contact

• Title: Dr. Daniel McIsaac
• Organization: The Ottawa Hospital

dmcisaac@toh.ca

613-761-4940

Study Officials

• Daniel McIsaac, MD, MPH

  Department of Anesthesiology and Pain Medicine, University of Ottawa, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 4, 2018
• Study Start: April 1, 2009
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2018
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share