Impact of Peripheral Nerve Blockade on Outcomes After Total Knee Replacement

Pain Clinical Trial

Official title:

Impact of Peripheral Nerve Blockade on Outcomes After Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742961
• Other study ID #: DM1
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: April 18, 2016
• Start date: April 2002
• Est. completion date: March 2014

Study information

• Verified date: April 2016
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Description:

This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient and health system outcomes after elective total knee replacement surgery.

The investigators will develop a non-parsimonious propensity score to control for potential indication bias and confounding in this observational study. Using the propensity score the investigators will match patients who receive a peripheral nerve block to a patient who did not to estimate the independent association of peripheral nerve blocks with our study outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178214
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first primary total knee replacement during the study period

Exclusion Criteria:

• Revision arthroplasty

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Other:
• Peripheral nerve block
A physician billing code for deposition of a local anesthetic solution around an anatomically defined nerve or nerve plexus

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
Other	All cause mortality	Identified from the Registered Person's Database that records the date of death for all residents of Ontario	Day of surgery to 30 days after surgery	Yes
Primary	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	No
Secondary	Hospital readmission	Determined from the Canadian Institute for Health Information Discharge Abstract Database through identification of a new record after discharge from the index hospitalization	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.	No
Secondary	In-hospital fall	Determined using validated International Classification of Diseases Tenth edition codes for falls from the index hospitalization Discharge Abstract Database record	hospital admission	Yes
Secondary	Emergency department visit	Defined as the creation of a record in the National Ambulatory Care Reporting System for an emergency department visit that occurs after discharge and before 30 days after discharge	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.	No