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AzTrials

Anesthesia MorbidityNCT04203732

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

An observational study of Anesthesia Morbidity and Osteoarthritis, Knee, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Anesthesia Type
Type of treatment
Surgery or procedure
How many people
12,466 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kaiser Permanente Northern California

    South San Francisco, California, 94080

Other trials in 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 assessing for difference in anesthetic techniques and outcomes.

Read the 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.

Being tested
Anesthesia Type
Keywords
Retrospective Cohort, Anesthetic Technique, Total Joint Arthroplasty
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anesthesia TypeProcedure or surgery

    Also called Anesthetic Technique

    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.

Study groups in NCT04203732
Study groupRoleWhat they receive
Total Joint ArthroplastyThe 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
Receives: Procedure: Anesthesia Type

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Morbidity

    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).

    Measured: 30-day postoperative

Secondary outcomes (8)

  1. Postoperative Mortality

    30-day postoperative mortality - all cause

    Measured: 30-day postoperative

  2. Postoperative readmission

    30-day postoperative readmission - all cause

    Measured: 30-day postoperative

  3. Intraoperative blood loss and transfusion rates

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

    Measured: Day of surgery

  4. Intraoperative opioid use

    Defined by type of analgesic medication and total morphine equivalence

    Measured: Day of surgery

  5. Postoperative opioid use

    Defined by type of analgesic medication and total morphine equivalence

    Measured: Day of surgery

  6. Postoperative Pain Scores

    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.

    Measured: Day of surgery

  7. Postoperative nausea and vomiting

    Rate of PONV after surgery

    Measured: Day of surgery

  8. Length of postsurgical hospital stay

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

    Measured: Day of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
12,466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04203732
Sponsor's protocol ID
1502384-1
Status last verified
Apr 2021
First submitted
16 Dec 2019
Last updated
9 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu VX, Rosas E, Hwang J, Cain E, Foss-Durant A, Clopp M, Huang M, Lee DC, Mustille A, Kipnis P, Parodi S. Enhanced Recovery After Surgery Program Implementation in 2 Surgical Populations in an Integrated Health Care Delivery System. JAMA Surg. 2017 Jul 19;152(7):e171032. doi: 10.1001/jamasurg.2017.1032. Epub 2017 Jul 19.

    PubMed 28492816

  • Berger RA, Sanders SA, Thill ES, Sporer SM, Della Valle C. Newer anesthesia and rehabilitation protocols enable outpatient hip replacement in selected patients. Clin Orthop Relat Res. 2009 Jun;467(6):1424-30. doi: 10.1007/s11999-009-0741-x. Epub 2009 Feb 28.

    PubMed 19252961

  • Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.

    PubMed 11118174

  • Holte K, Kehlet H. Epidural anaesthesia and analgesia - effects on surgical stress responses and implications for postoperative nutrition. Clin Nutr. 2002 Jun;21(3):199-206. doi: 10.1054/clnu.2001.0514.

    PubMed 12127927

  • Hu S, Zhang ZY, Hua YQ, Li J, Cai ZD. A comparison of regional and general anaesthesia for total replacement of the hip or knee: a meta-analysis. J Bone Joint Surg Br. 2009 Jul;91(7):935-42. doi: 10.1302/0301-620X.91B7.21538.

    PubMed 19567860

  • Memtsoudis SG, Sun X, Chiu YL, Stundner O, Liu SS, Banerjee S, Mazumdar M, Sharrock NE. Perioperative comparative effectiveness of anesthetic technique in orthopedic patients. Anesthesiology. 2013 May;118(5):1046-58. doi: 10.1097/ALN.0b013e318286061d.

    PubMed 23612126

  • Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013 Feb 6;95(3):193-9. doi: 10.2106/JBJS.K.01682.

    PubMed 23269359

  • Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.

    PubMed 10740539

  • Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anaesthesia improve outcome after total hip arthroplasty? A systematic review. Br J Anaesth. 2009 Sep;103(3):335-45. doi: 10.1093/bja/aep208. Epub 2009 Jul 23.

    PubMed 19628483

  • Kehlet H, Aasvang EK. Regional or general anesthesia for fast-track hip and knee replacement - what is the evidence? F1000Res. 2015 Dec 15;4:F1000 Faculty Rev-1449. doi: 10.12688/f1000research.7100.1. eCollection 2015.

    PubMed 26918127

  • Harsten A, Kehlet H, Toksvig-Larsen S. Recovery after total intravenous general anaesthesia or spinal anaesthesia for total knee arthroplasty: a randomized trial. Br J Anaesth. 2013 Sep;111(3):391-9. doi: 10.1093/bja/aet104. Epub 2013 Apr 11.

    PubMed 23578860

  • 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.

    PubMed 25522681

  • Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992 Jun;45(6):613-9. doi: 10.1016/0895-4356(92)90133-8.

    PubMed 1607900

  • 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.

    PubMed 34992150

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia Morbidity and Osteoarthritis, Knee, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Morbidity (time frame: 30-day postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04203732, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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