Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

Postoperative Complications Clinical Trial

Official title:

Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309644
• Other study ID #: GMH1
• Status: Completed
• Phase: N/A
• First received: October 10, 2017
• Last updated: October 24, 2017
• Start date: April 2011
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• 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 Ottawa, Ontario.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ontario residents

• Aged 18 years and older

• Elective ambulatory shoulder surgery

Exclusion Criteria:

• Emergency Surgery

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• Peripheral nerve blockade
Participants who receive a peripheral nerve block identified through the medical chart.
• No peripheral nerve blockade
Participants who did not receive a peripheral nerve block identified through the medical chart.

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From day of surgery to 30 days after surgery
Secondary	Health system costs in the 30 days after surgery	Calculated using validated algorithms	From day of surgery to 30 days after surgery