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

Sponsor
Kaiser Permanente (Other)
Overall Status
Completed
CT.gov ID
NCT04203732
Collaborator
(none)
12,466
Enrollment
1
Location
12
Actual Duration (Months)
1039.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anesthesia Type

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 Design

Study Type:
Observational
Actual Enrollment :
12466 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Anesthetic Techniques in Outpatient Total Joint Replacement Surgery in an Integrated Health Care Delivery System
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Morbidity [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).

    Secondary Outcome Measures

    1. Postoperative Mortality [30-day postoperative]

      30-day postoperative mortality - all cause

    2. Postoperative readmission [30-day postoperative]

      30-day postoperative readmission - all cause

    3. Intraoperative blood loss and transfusion rates [Day of surgery]

      Measurement of blood loss by mL recorded on record. Measurement of packed red blood cells transfused by unit pack.

    4. Intraoperative opioid use [Day of surgery]

      Defined by type of analgesic medication and total morphine equivalence

    5. Postoperative opioid use [Day of surgery]

      Defined by type of analgesic medication and total morphine equivalence

    6. Postoperative Pain Scores [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.

    7. Postoperative nausea and vomiting [Day of surgery]

      Rate of PONV after surgery

    8. Length of postsurgical hospital stay [Day of surgery]

      Length of time defined from end of intraoperative time to discharge from hospital time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Northern California South San Francisco California United States 94080

    Sponsors and Collaborators

    • Kaiser Permanente

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kaiser Permanente
    ClinicalTrials.gov Identifier:
    NCT04203732
    Other Study ID Numbers:
    • 1502384-1
    First Posted:
    Dec 18, 2019
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kaiser Permanente
    Retrospective Cohort
    Anesthetic Technique
    Total Joint Arthroplasty
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Osteoarthritis, Hip
    Anesthetics

    Study Results

    No Results Posted as of Apr 9, 2021