Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

Completed

• Conditions: Postoperative Complications
• Interventions: Other: Peripheral nerve blockade; Other: No peripheral nerve blockade

• Registration Number: NCT03309644
• 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 Ottawa, Ontario.

Detailed 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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-13
• Results First Submitted: 2023-10-12
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Results First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1623

Inclusion Criteria

• Ontario residents
• Aged 18 years and older
• Elective ambulatory shoulder surgery

Exclusion Criteria

• Emergency Surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peripheral nerve block	Peripheral nerve blockade	Peripheral nerve block
No peripheral nerve block	No peripheral nerve blockade	No peripheral nerve block

Primary Outcome Measures

Name	Time	Method
Postoperative Complication	From day of surgery to 30 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Health System Costs in the 30 Days After Surgery	From day of surgery to 30 days after surgery	Calculated using validated algorithms

Trial Locations

Locations (1)

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada