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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544775
• Other study ID #: GMH2
• Status: Completed
• Start date: April 1, 2009
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• Isolated General Anesthesia
No nerve block identified through physician billing codes
• Peripheral Nerve Block
Nerve block identified through physician billing codes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 7 days of surgery, and 4) death from any cause	Date of surgery to 7 days after surgery or death date, whichever came first
Secondary	Health system costs	Costs will be calculated using standardized patient-level costing algorithms.	Date of surgery to 7 days after surgery or death date, whichever came first
Secondary	Neurology consultations or diagnostics	Occurrence of neurology consult and/or nerve conduction study	Date of surgery to 90 days after surgery or death date, whichever came first