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

Completed

• Conditions: Postoperative Complications
• Interventions: Procedure: Isolated General Anesthesia; Procedure: Peripheral Nerve Block

• Registration Number: NCT03544775
• Lead Sponsor: Ottawa Hospital Research Institute

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.

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 Timeline

• Study Start: 2009-04-01
• Primary Completion: 2016-03-31
• Study Completion: 2018-03-31
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-04
• Results First Submitted: 2023-10-14
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Results First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59644

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Isolated General Anesthesia	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.
Peripheral Nerve Block	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Death, Admission, Readmission or Emergency Department Visits	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

Secondary Outcome Measures

Name	Time	Method
Health System Costs	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.
Neurology Consultations or Diagnostics	Date of surgery to 90 days after surgery or death date, whichever came first	Occurrence of neurology consult and/or nerve conduction study