Evaluation of Anesthetic Techniques in Outpatient Total Joint Replacement Surgery in an Integrated Health Care Delivery System

April 8, 2021 updated by: Kaiser Permanente
The study is a retrospective cohort study of adult patients undergoing outpatient primary unilateral total knee or total hip replacement surgeries from 2017 to 2019 assessing for difference in anesthetic techniques and outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a retrospective cohort study of adult patients undergoing outpatient primary unilateral total knee or total hip replacement surgeries from 2017 to 2019. The purpose of the study is to evaluate the effects of anesthetic techniques for primary total joint replacement in Northern California Kaiser Permanente. The primary objective is to determine if there are clinically and statistically significant differences between the outcomes of general anesthesia and neuraxial anesthesia.

Study Type

Observational

Enrollment (Actual)

12466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente Northern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary total joint surgery patients who undergo unilateral total knee replacement or total hip replacement for the first time during the study years of 2017 to 2019.

Description

Inclusion Criteria:

  • ASA 1 - IV patients
  • Age > 18
  • Primary total hip/knee replacement

Exclusion Criteria:

  • Total joint replacement for oncologic tumors
  • Emergent surgery
  • Age < 17
  • Pregnant Female
  • Neuraxial anesthesia conversion to general anesthesia
  • Revision total joint replacement
  • Bilateral total joint replacement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total Joint Arthroplasty
The cohort includes patients undergoing outpatient primary total joint replacement surgeries from 2017 to 2019. Primary total joint surgery is defined as patients who undergo unilateral total knee replacement or total hip replacement for the first time during the study years
Procedure: Anesthesia Type
The anesthetic type either general anesthesia or neuraxial anesthesia is the intervention type for patients undergoing primary total joint arthroplasty of the knee or hip.
Other Names:
  • Anesthetic Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Morbidity
Time Frame: 30-day postoperative
30-day Postoperative Morbidity including surgical site infection (defined as infection involving the skin or subcutaneous tissue of the incision, deep incisional infection defined as infected tissue below the subcutaneous tissue including fascia and muscle), major coronary events (defined as nonfatal myocardial infarction, heart failure, ventricular tachycardia, cardiac arrest), pneumonia, urinary tract infection, venous thromboembolism, pulmonary embolism, cerebrovascular accident, renal injury/failure (Defined as increase in baseline creatinine 2 fold/3fold respectively).
30-day postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Mortality
Time Frame: 30-day postoperative
30-day postoperative mortality - all cause
30-day postoperative
Postoperative readmission
Time Frame: 30-day postoperative
30-day postoperative readmission - all cause
30-day postoperative
Intraoperative blood loss and transfusion rates
Time Frame: Day of surgery
Measurement of blood loss by mL recorded on record. Measurement of packed red blood cells transfused by unit pack.
Day of surgery
Intraoperative opioid use
Time Frame: Day of surgery
Defined by type of analgesic medication and total morphine equivalence
Day of surgery
Postoperative opioid use
Time Frame: Day of surgery
Defined by type of analgesic medication and total morphine equivalence
Day of surgery
Postoperative Pain Scores
Time Frame: Day of surgery
Numerical Rating Scale of postsurgical pain measured until discharge from hospital. Numerical rating scale for pain is described as a scale from a minimum of 0, associated with no pain, to a maximum of 10, associated with the worst possible pain. A higher number is associated with a worse outcome.
Day of surgery
Postoperative nausea and vomiting
Time Frame: Day of surgery
Rate of PONV after surgery
Day of surgery
Length of postsurgical hospital stay
Time Frame: Day of surgery
Length of time defined from end of intraoperative time to discharge from hospital time
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Edward N Yap, MD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1502384-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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