Clinical trial NCT04203732: Evaluation of Anesthetic Techniques in Outpatient Total Joint Replacement Surgery in an Integrated Health Care Delivery System
Official title: Evaluation of Anesthetic Techniques in Outpatient Total Joint Replacement Surgery in an Integrated Health Care Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Morbidity
Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Retrospective Cohort
Anesthetic Technique
Total Joint Arthroplasty
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 12466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Morbidity
timeFrame: 30-day postoperative
Secondary outcomes:
measure: Postoperative Mortality
timeFrame: 30-day postoperative
measure: Postoperative readmission
timeFrame: 30-day postoperative
measure: Intraoperative blood loss and transfusion rates
timeFrame: Day of surgery
measure: Intraoperative opioid use
timeFrame: Day of surgery
measure: Postoperative opioid use
timeFrame: Day of surgery
measure: Postoperative Pain Scores
timeFrame: Day of surgery
measure: Postoperative nausea and vomiting
timeFrame: Day of surgery
measure: Length of postsurgical hospital stay
timeFrame: Day of surgery
Other outcomes:
Locations:
city: South San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Edward N Yap, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Harsten A, Kehlet H, Ljung P, Toksvig-Larsen S. Total intravenous general anaesthesia vs. spinal anaesthesia for total hip arthroplasty: a randomised, controlled trial. Acta Anaesthesiol Scand. 2015 Mar;59(3):298-309. doi: 10.1111/aas.12456. Epub 2014 Dec 18.
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citation: Yap E, Wei J, Webb C, Ng K, Behrends M. Neuraxial and general anesthesia for outpatient total joint arthroplasty result in similarly low rates of major perioperative complications: a multicentered cohort study. Reg Anesth Pain Med. 2022 May;47(5):294-300. doi: 10.1136/rapm-2021-103189. Epub 2022 Jan 6.