NCT02742961

Brief Summary

Pain is common after knee replacement surgery and can impact a variety of patient outcomes. Peripheral nerve blocks provide improved pain control and may improve function. However, their impact on other outcomes is poorly described. Therefore, this comparative effectiveness study will estimate the independent association between nerve blocks and health outcomes after knee replacement surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178,214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

11.9 years

First QC Date

April 13, 2016

Last Update Submit

April 18, 2016

Conditions

Keywords

orthopedicsanesthesiologynerve blocklength of stayPatient readmission

Outcome Measures

Primary Outcomes (1)

  • Hospital length of stay

    Determined from the Canadian Institute for Health Information Discharge Abstract Database record for the index hospitalization

    Day of surgery to day of discharge, or up to 365 days, whichever comes first

Secondary Outcomes (3)

  • Hospital readmission

    The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any readmission in this time period will be considered an event.

  • In-hospital fall

    hospital admission

  • Emergency department visit

    The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any emergency department visit in this time period will be considered an event.

Other Outcomes (1)

  • All cause mortality

    Day of surgery to 30 days after surgery

Study Arms (2)

Peripheral nerve block

Intervention arm. Participants who receive a peripheral nerve block identified through submission of an appropriate physician billing code

Other: Peripheral nerve block

No peripheral nerve block

Control arm. Participants who do not receive a peripheral nerve block identified through lack of a submission of an appropriate physician billing code

Interventions

A physician billing code for deposition of a local anesthetic solution around an anatomically defined nerve or nerve plexus

Peripheral nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults having their first total knee replacement during the study period

You may qualify if:

  • first primary total knee replacement during the study period

You may not qualify if:

  • Revision arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y4E9, Canada

Location

MeSH Terms

Conditions

PainOsteoarthritis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 19, 2016

Study Start

April 1, 2002

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 19, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations