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Completed

NCT Number: NCT04203732

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

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.

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Key information

Conditions

Anesthesia Morbidity Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California

South San Francisco, California, 94080, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anesthesia Type

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Postoperative Mortality

    Time frame: 30-day postoperative

    30-day postoperative mortality - all cause

  2. Postoperative readmission

    Time frame: 30-day postoperative

    30-day postoperative readmission - all cause

  3. 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.

  4. Intraoperative opioid use

    Time frame: Day of surgery

    Defined by type of analgesic medication and total morphine equivalence

  5. Postoperative opioid use

    Time frame: Day of surgery

    Defined by type of analgesic medication and total morphine equivalence

  6. 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.

  7. Postoperative nausea and vomiting

    Time frame: Day of surgery

    Rate of PONV after surgery

  8. Length of postsurgical hospital stay

    Time frame: Day of surgery

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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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