Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

NCT03309644 | Completed Results

• 1 other identifier: GMH1
• Study Type: observational
• Target: 1,623
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

Unplanned admissions; Visits to the ED; Readmissions; Death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Health System Costs in the 30 Days After Surgery

  From day of surgery to 30 days after surgery

Study Arms (2)

Peripheral nerve block

Peripheral nerve block

Other: Peripheral nerve blockade

No peripheral nerve block

No peripheral nerve block

Other: No peripheral nerve blockade

Interventions

Peripheral nerve blockade OTHER

Participants who receive a peripheral nerve block identified through the medical chart.

Peripheral nerve block

No peripheral nerve blockade OTHER

Participants who did not receive a peripheral nerve block identified through the medical chart.

No peripheral nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 Ottawa, Ontario, Canada.

You may qualify if:

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

You may not qualify if:

• Emergency Surgery

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

• Hamilton GM, Ramlogan R, Lui A, McCartney CJL, Abdallah F, McIsaac DI. Association of peripheral nerve blocks with postoperative outcomes in ambulatory shoulder surgery patients: a single-centre matched-cohort study. Can J Anaesth. 2019 Jan;66(1):63-74. doi: 10.1007/s12630-018-1234-8. Epub 2018 Oct 17.

  PMID: 30334192 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

There is risk of exposure misclassification bias. Confounding bias may have influenced the receipt of specific anesthesia interventions and outcomes. This study did not examine longer-term outcomes. We do not have data that specifically link the anesthesiologist or surgeon to the patient. This study examines data obtained from a single academic health sciences centre. Given the unexpected lower rates of adverse events in our institution, results may be due to this study being underpowered.

Results Point of Contact

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

dmcisaac@toh.ca

613-761-4940

Study Officials

• Daniel I McIsaac, MD, MPH

  Department of Anesthesiology and Pain Medicine, University of Ottawa

  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: October 10, 2017
• First Posted: October 13, 2017
• Study Start: April 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)