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

NCT04203732 | Completed DMC

• 1 other identifier: 1502384-1
• Study Type: observational
• Target: 12,466
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Morbidity; Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Retrospective Cohort; Anesthetic Technique; Total Joint Arthroplasty

Outcome Measures

Primary Outcomes (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).

  30-day postoperative

Secondary Outcomes (8)

• Postoperative Mortality

  30-day postoperative

• Postoperative readmission

  30-day postoperative

• Intraoperative blood loss and transfusion rates

  Day of surgery

• Intraoperative opioid use

  Day of surgery

• Postoperative opioid use

  Day of surgery

Study Arms (1)

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

Interventions

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.

Also known as: Anesthetic Technique

Total Joint Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northern California

South San Francisco, California, 94080, United States

Location

Related Publications (14)

• 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.

  PMID: 28492816 BACKGROUND

• 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.

  PMID: 19252961 BACKGROUND

• 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.

  PMID: 11118174 BACKGROUND

• 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.

  PMID: 12127927 BACKGROUND

• 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.

  PMID: 19567860 BACKGROUND

• 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.

  PMID: 23612126 BACKGROUND

• 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.

  PMID: 23269359 BACKGROUND

• 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.

  PMID: 10740539 BACKGROUND

• 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.

  PMID: 19628483 BACKGROUND

• 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.

  PMID: 26918127 BACKGROUND

• 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.

  PMID: 23578860 BACKGROUND

• 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.

  PMID: 25522681 BACKGROUND

• 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.

  PMID: 1607900 BACKGROUND

• 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.

  PMID: 34992150 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Edward N Yap, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)