Osteoarthritis, Knee Clinical Trial
Official title:
Evaluation of Anesthetic Techniques in Outpatient Total Joint Replacement Surgery in an Integrated Health Care Delivery System
NCT number | NCT04203732 |
Other study ID # | 1502384-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2020 |
Est. completion date | December 31, 2020 |
Verified date | April 2021 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 12466 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Northern California | South San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente |
United States,
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. — View Citation
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. — View 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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Kehlet H, Aasvang EK. Regional or general anesthesia for fast-track hip and knee replacement - what is the evidence? F1000Res. 2015 Dec 15;4. pii: F1000 Faculty Rev-1449. doi: 10.12688/f1000research.7100.1. eCollection 2015. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. Erratum in: Anesthesiology. 2016 Sep;125(3):610. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postoperative Mortality | 30-day postoperative mortality - all cause | 30-day postoperative | |
Secondary | Postoperative readmission | 30-day postoperative readmission - all cause | 30-day postoperative | |
Secondary | 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. | Day of surgery | |
Secondary | Intraoperative opioid use | Defined by type of analgesic medication and total morphine equivalence | Day of surgery | |
Secondary | Postoperative opioid use | Defined by type of analgesic medication and total morphine equivalence | Day of surgery | |
Secondary | 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. | Day of surgery | |
Secondary | Postoperative nausea and vomiting | Rate of PONV after surgery | Day of surgery | |
Secondary | Length of postsurgical hospital stay | Length of time defined from end of intraoperative time to discharge from hospital time | Day of surgery |
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